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56.0 years
0 Lacs
Pune, Maharashtra, India
On-site
Senior RAQA Associate - ANZ About Medline: About Medline India: Medline India was setup in 2010 in Pune, primarily as an offshore Development centre and to augment resources for Medline Industries LP headquartered in Chicago, USA. We are a 1500+ strong and growing team of technology, finance & and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. We are proud to be certified as a ‘Great Place to Work’ by the Great Place to Work Institute® (India) for the duration June 2025 – June 2026. We are an organization with a conducive work environment, ample opportunities to learn, contribute and grow with a highly empowered & engaged team. We encourage our people to share their best ideas and create new opportunities for our customers and ourselves to work together to solve today’s toughest healthcare challenges. About Medline Industries, LP: Established in 1966, Medline Industries LP is a renowned global healthcare organisation boasting 56 years of consecutive sales growth, exceeding $21 billion in annual sales. With a workforce of over 36,000 professionals spread across the globe, we operate in more than 125 countries and territories. As the largest privately held manufacturer and distributor of medical supplies in the United States, Medline is uniquely positioned to offer comprehensive products, education, and support across the continuum of care. At present, Medline Industries, LP holds the esteemed position as the #1 market leader, delivering an extensive portfolio of over 550,000 medical products and clinical solutions. Our clientele includes hospitals, extended care facilities, surgery centres, physician offices, home care agencies, providers, and retailers. We're proud to be recognised by Forbes as one of America’s Best Large Employers and Best Employers for Women. Additionally, the Chicago Tribune has consistently named us a Top Workplace for the past 12 years. Job Description Our Pune, India location currently has an exciting opportunity for a Senior Regulatory Affairs Associate within the Regulatory Affairs team for the ANZ market. This role plays a key part in upholding quality standards aligned with our strategic engineering objectives. This role will ensure regional-specific RAQA requirements for ANZ are identified, represented, and included in the manufacturer’s technical documentation supporting local registrations. In addition to supporting ongoing QA & RA functions, this position contributes to both new product development and legacy engineering projects related to the ANZ market. We are looking for someone who thrives in a team environment, demonstrates a strong sense of urgency, and can build and maintain effective working relationships with peers, customers, and suppliers. The role reports to the QRA Manager in India and the Senior Manager RAQA Australia. Key Responsibilities RA Activities: Create and maintain documentation to meet regional-specific requirements (e.g., EPC, Australian DoC). Ensure regional-specific requirements are documented within the LM technical file (e.g., technical file addendum covering regional testing arrangements). Ensure labels meet regional-specific requirements and Review and update label changes as needed. Identify regional-specific requirements impacted by changes. Facilitate coordination with relevant stakeholders and update technical file documentation to enable changes with minimal disruption (e.g., testing from new vendors, material validations). Assess, facilitate, and complete technical file documentation for new products. Build new technical files or expand the scope of existing technical files within the legal manufacturer’s certification framework to support New Product Introductions (NPI/NPL). Provide visibility and access to the local RA team to technical documentation for the provision of information in response to customer queries and tenders. Create and provide documentation for local registration submissions. Assist with application audits and respond to queries or investigations from local regulators. QA Activities: Work with relevant stakeholders to identify applicable standards and requirements to meet the “state-of-the-art” (SOTA) upon commercial expectations set for ANZ’s product range. Identify discrepancies in the technical file SOTA standards compared to regional-specific requirements. Coordinate with contract manufacturers and external laboratories to obtain test reports, perform testing and implement ongoing testing processes demonstrating compliance requirements for ANZ’s product range and maintain accreditations as appropriate. Complete assessments and validations/testing to expedite change processing (e.g., material validations, vendor assessments, performance testing/equivalencies). Conduct document reviews to validate claims in marketing collateral and labels. Develop equivalency and justification statements, perform risk assessments to support these, and create customer letters for performance test claims. Prepare Certificates of Analysis (CoA) or Certificates of Conformance (CoC) for customers. Draft statements to substantiate claims and ensure adherence to SOTA standards in response to customer queries and tender submissions (e.g., explaining differences in technical file standards like US/FDA and ISO vs. EU/EN). Must Have Degree or higher in B. Tech (Biomedical)/ B.E. (Mech)/ M. Pharm. (Quality Assurance). 3-to-5-years work experience within the Medical Device industry with a strong Regulatory or Quality background. Familiarity with 21 CFR Part 820, EU MDR 2017/745, MDSAP, ISO 13485, ANZ MD regulation, and requirements. Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards. Demonstrates excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders, ensuring alignment and understanding. Proficiency in MS Office (Word, Excel, PowerPoint, Outlook): Able to create and format professional documents, analyse and organise data, prepare clear presentations, and manage communication and scheduling effectively. Strong attention to detail and organisational skills: Ensures accuracy and compliance in data entry and documentation, maintains structured records, and manages multiple tasks efficiently. Demonstrates a strong focus on outcomes by setting clear goals, taking ownership, and consistently delivering high-quality results that align with business objectives. Good to Have Experience in working with the TGA/ANZ regulatory environment. Experience with ETQ Reliance, SAP, and QAD platforms. Experience with QMS and technical documentation (e.g., interpreting standards, conducting gap analyses, producing reports, developing documentation, performing risk assessments). Exposure to global quality systems and multi-country document management. Ability to work independently and in a global team environment. Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards. Exposure with continuous improvement and a creative environment adds value. Working Hours: 10.30 am to 7.30 pm IST
Posted 1 day ago
0 years
0 Lacs
Hyderabad, Telangana, India
On-site
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. We are looking for an ETQ Developer who will be responsible for designing, developing, and maintaining various modules of EtQ Reliance platform by implementing system configurations and customizations while leveraging Out-of-Box features. Modifications of existing and new features will require you to write new ETQ Script to perform complex configurations and/or modify existing script within the EtQ Reliance platform. You will collaborate with cross-functional teams to gather requirements, develop solutions, and ensure the successful implementation of quality management systems while working in a regulated environment. Your Key Responsibility: Collaborate with stakeholders to gather requirements and define software functionalities and limitations. Design and develop software applications on the EtQ Reliance platform based on business requirement while working with an Agile team Configure or customize the EtQ Reliance system to meet business needs. Conduct unit testing to ensure software quality and performance. Peer review of code/configurations. Create and maintain technical documentation, including system configurations and workflows. Perform promotions of solution to higher environments while following business defined SDLC process. Create and execute test scripts to qualify code promotions (IQ/OQ) Provide technical support and training to end-users on the EtQ Reliance system as needed. Troubleshoot and resolve issues and bugs in the production environment while supporting root cause analysis and impact assessments. Collaborate with technical leads, scrum masters to define project scope, timelines, and deliverables and follow Agile process. Stay up-to-date with the latest EtQ Reliance features, functionalities, and industry trends. To qualify for the role, you must have Bachelor’s degree in Computer Science, Software Engineering, or a related field. Strong background in coding with Python and Java Strong background in Advanced SQL and DBMS Strong knowledge of the EtQ Reliance platform and its modules. Excellent problem-solving and analytical skills. Previous experience as an EtQ Developer including: Exposure to basic configurations to setup workflows, forms, views, notifications. Exposure to advanced configurations and customizations in ETQ using ETQScript. Experience with handling internal and external system integrations in ETQ Experience with creating custom Views by leveraging multi-valued fields spread across multiple forms and creating embedded views within forms in ETQ Experience with creating and maintaining scheduled jobs to enable automation and system integrations in ETQ Understanding of Master Keyword List and Master Names List and how to create and maintain them in Reliance Experience with using office integration tool to integrate MS Office with ETQ Reliance forms Access control in ETQ Reliance - define and maintain access roles and user groups in Reliance Experience with data migration in ETQ with knowhow of data migration best practices when operating in a regulated environment Ability to work independently and manage multiple priorities while following Agile methodology Strong communication and collaboration skills. Good to have: ETQ Reliance Promotion Certification Intermediate or Advanced ETQ Designer certification EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.
Posted 3 days ago
150.0 years
0 Lacs
Pune
On-site
You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you’ll help us deliver better care for billions of people around the world. It starts with YOU. In this role, you will: As a Senior Quality Engineer at the Pune Plant, you will report directly to the Quality Manager. In this role, you will be responsible for conducting routine quality checks in accordance with Kimberly-Clark’s quality guidelines and ensuring full compliance with all applicable regulatory requirements from a quality perspective. You will also support activities related to Quality Management System (QMS) compliance and continuous improvement. Additionally, you will be involved in the deployment of global and segment-level quality initiatives, standards, and tools. A key part of your responsibilities will be strong quality mindset within the team. you will be expected to drive and embed the quality agenda across all plant operations. Drive RFT Performance across the value chain (Procure, Make, Move, Sell) to ensure quality from sourcing to delivery. Ensure Compliance with Kimberly-Clark’s QMS, regulatory standards, and product category requirements (BCC, AFC). Lead Quality Investigations, including RCA and CAPA, ensuring timely and effective resolution of incidents. Manage Change Controls by leading risk assessments (FMEA) and coordinating quality input for trials, product changes, and new initiatives. Collaborate with Suppliers to resolve quality issues and ensure compliance with standards. Coordinate QA Activities with internal stakeholders during product and process changes. Support Continuous Improvement through data analysis and quality improvement projects. Conduct Training on GMP, hygiene, product safety, and quality tools to build team capability. Manage Customer Feedback by cascading complaints and promoting problem-solving at the shop floor level. Maintain QA Systems including non-conformance reporting, PASS data, EtQ protocols, and lab/tester certifications. Benchmark & Implement Best Practices by collaborating with other KC sites. About Us Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn’t exist without talented professionals, like you. At Kimberly-Clark, you’ll be part of the best team committed to driving innovation, growth and impact. We’re founded on more than 150 years of market leadership, and we’re always looking for new and better ways to perform – so there’s your open door of opportunity. It’s all here for you at Kimberly-Clark. Led by Purpose. Driven by You About You You perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we’re constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you’ll experience Flex That Works: flexible work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business. In one of our technical roles, you’ll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center. To succeed in this role, you will need the following qualifications: Key Qualifications and Experiences: Minimum Graduate in Engineering/Postgraduate in Science. Minimum 4-5 year of experience in manufacturing function. Ability to work effectively with computer systems and a thorough knowledge of current office practices and procedures. Proficiency in Microsoft applications such as Outlook, Teams, Excel, Word, PowerPoint. High resilience and energy in a fast paced and changing environment Good listening ability Ability to win with limited resources Ability to work collaboratively and to develop a collaborative winning mindset. Analytical capability, and able to make quick decisions to solve issues Ability to work as a team player Demonstrated ability to work with cross functional teams effectively. To Be Considered Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role. In the meantime, please check out the careers website. And finally, the fine print…. For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position. Employment is subject to verification of pre-screening tests, which may include drug screening, background check, and DMV check. #LI-Onsite .
Posted 6 days ago
7.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
Job Title: Project Quality Engineer Locations: Pan India & Global Reporting: HOD About Newen Systems Newen Systems is India’s leading power conversion and energy storage solutions provider, driving energy transition and grid stability. Newen’s state of the art manufacturing facilities at Vadodara is at the heart of driving innovation and GW scale energy revolution for the world. With 3,000+ MW of battery storage deployed across 65+ countries in all seven continents, Newen Systems in technical collaboration with Dynapower is delivering BESS, Green H2, Microgrid and e-mobility infrastructure solutions to customers in India and around the world. Newen’s cutting edge energy management system is helping customers maximize their energy investment in ways it was not imagined earlier. Newen is uniquely positioned globally to provide EMS and PCS under one roof enabling customers to do integration tests within the factory rather than on site saving them time and money. As we expand, we are looking for intrapreneurial talent who have the passion to drive energy transition and deliver solutions to drive sustainability on a global scale. Job Summary: The Electrical Project Quality Engineer is responsible for ensuring that all electrical installations and systems meet the required quality standards and comply with applicable codes, standards, and project specifications. This role involves planning, implementing, and monitoring quality control procedures throughout the project lifecycle. Key Tasks: Develop and implement project-specific Quality Plans, Inspection & Test Plans (ITPs), and checklists for electrical systems. Conduct inspections and tests on electrical installations including cable trays, wiring, panels, grounding, lighting, and control systems. Review and verify electrical drawings, specifications, and material submittals for compliance. Coordinate with construction teams, subcontractors, and suppliers to ensure quality standards are met. Monitor and document all quality control activities and maintain comprehensive records. Identify non-conformities, issue NCRs (Non-Conformance Reports), and ensure corrective actions are implemented. Participate in internal and external audits and support continuous improvement initiatives. Ensure compliance with safety regulations and electrical codes (e.g., NEC, IEC, IEEE). Provide technical support and training to site personnel on quality procedures and standards. Skills: Technical Skills: Electrical Engineering Knowledge: Strong understanding of electrical systems, components, and standards (e.g., IEC, NEC, IEEE). Quality Management Systems (QMS): Familiarity with ISO 9001 and other quality frameworks. Inspection & Testing: Proficiency in electrical testing methods (e.g., insulation resistance, continuity, voltage drop). Documentation & Reporting: Ability to prepare and manage ITPs, checklists, NCRs, and quality reports. Standards & Codes Compliance: Knowledge of national and international codes relevant to the project (e.g., MNRE, BIS for solar). Root Cause Analysis: Skills in identifying, analyzing, and resolving quality issues using tools like 5 Whys, Fishbone Diagram, etc. Analytical & Problem-Solving Skills Attention to detail in identifying defects or deviations. Ability to interpret technical drawings and specifications. Strong troubleshooting skills for on-site quality issues Tools & Software MS Office Suite : Especially Excel and Word for documentation and reporting. AutoCAD / Electrical CAD : For reviewing and marking up drawings. Quality Management Software : Tools like SAP QM, ETQ, or custom project management platforms. Testing Equipment : Familiarity with multimeters, insulation testers, and other electrical QA tools. Qualifications & Experience: Bachelor’s degree in electrical/Electronic engineering or related field. Minimum 7 years of experience in electrical QA/QC roles within BESS or industrial projects. Strong knowledge of electrical systems, standards, and testing procedures. Excellent communication, documentation, and problem-solving skills.
Posted 1 week ago
12.0 years
0 Lacs
Aurangabad, Maharashtra, India
On-site
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Quality Job Sub Function Quality Control Job Category People Leader All Job Posting Locations: Aurangabad, Maharashtra, India Job Description SECTION 1: JOB SUMMARY* Under the direction of the Director Quality Operations/Site Quality Head, with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Quality Control support to the New Products Introduction, Supply Chain, and directly supervises Quality Control associates and non-exempts in day-to-day activities supporting manufacturing lines, all in accordance with applicable regulations and Ethicon written specifications and quality standards. Defines India and/or functional strategies and contributes to global strategies for a Quality lab. Creates and manages multiple complex testing techniques/instruments that result in the accomplishment of multiple business objectives. Leads the analysis of highly complex issues and establishes resolutions and or decision points for programs and/or projects. Identifies novel scenarios and nascent scientific/technical opportunities and seeks to contribute to the improvement of processes that enable scientists to cultivate new scientific insights. Manager QC is responsible for the overall management of the quality laboratory. responsible for driving continuous Quality Excellence, maintaining supply chain compliance, providing franchise support, and communicating internal and external customer facing needs to Site Quality Leaders. This includes support in the delivery of critical initiatives for Medical Device and Supply Chain Quality. In addition, they will identify and facilitate the implementation of key capabilities at the site that will give the Quality team a competitive advantage. Plans, coordinates, and direct Quality control activities to ensure continuous production of products consistent with established quality & regulatory standards by performing the assigned duties and responsibilities to support manufacturing and timely delivery of product to customers. SECTION 2: DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Provides Management and Leadership in a laboratory environment. Manages laboratory resources to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers. Ensures all laboratory activities are conducted in accordance with government regulations, safety Requirements, Enterprise, Sector And Company Policies. Ensures the appropriate oversight and guidance for laboratory investigations including reviewing investigations to ensure that reports are consistent, complete and in alignment with applicable standards and procedures with appropriate content and references. Ensures cGMP compliance in all aspects of the laboratory functions. Ensures that all laboratory personnel have the required education and training to perform assigned job responsibilities. Ensures all relevant core competency training modules are deployed to the laboratory personnel and that all laboratory procedures are aligned with the MD&D and Enterprise Laboratory Standards. Ensures that laboratory equipment and systems are maintained in accordance with procedures and standards. Ensures that validated/verified test methods and qualified and calibrated instruments are used for quality testing activities. provides oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems. Provides oversight of all Laboratory Quality Systems including Laboratory Change Management activities. Provides oversight of Quality Agreements with Contract Laboratories to ensure excellent and appropriate communication between laboratories. Additionally, working with procurement to develop business agreements with Contract Laboratories. Ensures Reviewing and approving technical protocols and reports to support validation/verification and qualification activities. Ensures monitoring of laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. Provides audit support. Leads /sponsors the implementation of improvement initiatives to address recurring laboratory issues. Reviews and approves Quality Records (e.g. non-conformances, CAPA) related to laboratory events. Maintaining knowledge of the regulatory trends related to relevant laboratory testing. Communicating and elevating critical business related issues as well as opportunities to senior management. Planning, promoting and organizing required training activities related to different laboratory testing areas. Establishing and maintaining an annual operational budget. Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices. Promoting Good Saves safety culture. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed. ❖ Compliance & Training Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any violation or deviation to the immediate supervisor or appropriate authority. Complies with all training requirements to perform duties of the job. Ensure adherence/compliance to Records Management policies and procedures, as applicable. ❖ Accountability Maintains 5S states of laboratory, GLP & GMP in laboratory. Over all Laboratory accountability. Team building and credo. Laboratory metric & its review. Laboratory work as per current procedure and test method. Audit readiness within laboratory. 2.1 Authorities Chemical test / Microbiological test Raw Data/Report review and approve (As applicable) Laboratory Log book Review Rejection note approval Lab Investigation Report, Lab incident approve (As applicable) PR/PO approval Internal and Cross functional document approval through applicable PLM/ADAPTIV system EtQ (NC , CAPA, audit observation, change request) approval OPEX/CAPEX finance related approvals Review / Approve Instrument Qualification/calibration/PM/AMC / validations /service reports/TMV documentation. Approve Outward/Inward Gate pass (as applicable) SECTION 3: EXPERIENCE AND EDUCATION* Graduate/Postgraduate/Ph.D in Science degree, preferably in a relevant scientific/technical field/ Pharmaceutical Sciences and 12 or more years of relevant experience in QMS environment. ( OR A minimum of 12 years responsibility and experience in a highly regulated environment is required including a broad and deep working knowledge of the operating functions of quality and compliance, supply chain, material supply and material handling and control, product manufacturing and product packaging. Minimum 5 years of experience in Supervisory or Managerial cadre.An understanding and application of cGMP and internal/external Health Authority compliance expectations is required. Excellent communication, collaboration, and influencing skills across multiple functions and levels within the organization is required. Prior experience with regulatory inspections is desirable. Prior experience with project management, Lean, Six Sigma, Operational Excellence, change management training and/or certification is desirable. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* Technical Skills / Behavioral Skills Functional Competencies Understanding of theory, and practical applications, of experimental techniques within a Quality lab, as well as key processes and activities, and the interdependencies and interactions with other functions. Conducting audits of in-house Quality labs and contract/external Quality labs. Technical understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards. Implementing innovative approaches to solving technical problems and troubleshooting, with limited guidance from management or other scientific personnel, while maintaining a high level of cGMP awareness. Professional Competencies Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management. Quality & Compliance: Quality Mindset, Compliance Orientation, Environment Health & Safety Business Fundamentals: Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation, Business Partnering: Influencing, Change Management, Time Management, Global Mindset & Management.
Posted 1 week ago
4.0 years
0 Lacs
Pune, Maharashtra, India
On-site
Responsibilities What to expect Design, develop and modify software systems and custom components using modern dev stack. Debug applications, trace code, and find and fix bugs as well as identify software flaws, spot wrong implementation, and propose effective solutions. Actively participate in grooming meetings to define the feature specifications. Implement unit test cases that exercise and test the produced code. Regularly update stories including progress, status, and documentation (Release Notes & Modified Settings) for projects. Handle customer feedback on the delivered projects. Communicate with customers when applicable, to address and troubleshoot reported issues, which requires excellent skills in managing customer meetings, phone etiquette, etc. Effectively use the different development tools necessary to do the required job. For example: IDE, HTML editors, debugging tools, DB clients, SQL editors, … etc.). Demonstrate high quality technical and business documentation skills. Front-End Development Develop, modify, and maintain complex and interactive Web and Mobile applications using Angular, JavaScript, HTML5, and CSS. Develop and maintain the Java, JavaScript, and CSS libraries and events to control the client functionality. Troubleshoot and fix Client Side (Angular, JavaScript, CSS, and GUI) issues reported by testers. Develop prototypes and UI designs. Use the ETQ Designer tool to modify and maintain the UI of new and existing applications. Back-End Development Develop and maintain web applications using Java technology and based upon the ETQ Reliance platform. Develop and maintain Java classes and other resources to implement requirements and features Education / Qualifications B.S. Degree or higher in Computer Science, Computer Information Systems, Software Engineering, or related degree. 4+ years of experience implementing enterprise/SaaS applications for front end and back end. Experience in Java programming. Solid understanding of Object-oriented Programming (OOP) principles. Experience to Spring framework is a plus. Front end programming skills, including Angular, JavaScript, TypeScript, HTML, CSS, or other frameworks. Nodejs knowledge is a plus. Excellent communication skills, verbal, and written. Knowledge in RBDMS Oracle, SQL Server, or MySQL. Knowledge about coding design patterns is preferred. Exposure to microservices a plus. Exposure to AWS a plus. Experience developing cross-browser and cross-platform compatible solutions is a plus. About Hexagon Hexagon is a global leader in digital reality solutions, combining sensor, software and autonomous technologies. We are putting data to work to boost efficiency, productivity, quality and safety across industrial, manufacturing, infrastructure, public sector, and mobility applications. Hexagon’s Asset Lifecycle Intelligence division helps clients design, construct, and operate more profitable, safe, and sustainable industrial facilities. We empower customers to unlock data, accelerate industrial project modernization and digital maturity, increase productivity, and move the sustainability needle. Our technologies help produce actionable insights that enable better decision-making and intelligence across the asset lifecycle of industrial projects, leading to improvements in safety, quality, efficiency, and productivity, which contribute to Economic and Environmental Sustainability. Hexagon (Nasdaq Stockholm: HEXA B) has approximately 25,000 employees in 50 countries and net sales of approximately 5.4bn EUR. Learn more at hexagon.com and follow us @HexagonAB. Why work for Hexagon? At Hexagon, if you can see it, you can do it. Hexagon’s Asset Lifecyle Intelligence division puts their trust in you so that you can bring your ideas to life. We have emerged as one of the most engaged and enabled workplaces*. We are committed to creating an environment that is truly supportive by providing the resources you need to fully support your ambitions, no matter who you are or where you are in the world. In the recently concluded workplace effectiveness survey by Korn Ferry, a global HR advisory firm, Hexagon, Asset Lifecycle Intelligence division has emerged as one of the most Engaged and Enabled workplaces, when compared to similar organizations that Korn Ferry partners with. Everyone is welcome At Hexagon, we believe that diverse and inclusive teams are critical to the success of our people and our business. Everyone is welcome—as an inclusive workplace, we do not discriminate. In fact, we embrace differences and are fully committed to creating equal opportunities, an inclusive environment, and fairness for all. Respect is the cornerstone of how we operate, so speak up and be yourself. You are valued here.
Posted 1 week ago
5.0 - 12.0 years
0 Lacs
Aurangabad, Maharashtra
On-site
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Control Job Category: People Leader All Job Posting Locations: Aurangabad, Maharashtra, India Job Description: SECTION 1: JOB SUMMARY* Under the direction of the Director Quality Operations/Site Quality Head, with the objective of maintaining high quality standards for the product manufacturing process and compliance with regulatory requirements, administers Quality Control support to the New Products Introduction, Supply Chain, and directly supervises Quality Control associates and non-exempts in day-to-day activities supporting manufacturing lines, all in accordance with applicable regulations and Ethicon written specifications and quality standards. Defines India and/or functional strategies and contributes to global strategies for a Quality lab. Creates and manages multiple complex testing techniques/instruments that result in the accomplishment of multiple business objectives. Leads the analysis of highly complex issues and establishes resolutions and or decision points for programs and/or projects. Identifies novel scenarios and nascent scientific/technical opportunities and seeks to contribute to the improvement of processes that enable scientists to cultivate new scientific insights. Manager QC is responsible for the overall management of the quality laboratory. responsible for driving continuous Quality Excellence, maintaining supply chain compliance, providing franchise support, and communicating internal and external customer facing needs to Site Quality Leaders. This includes support in the delivery of critical initiatives for Medical Device and Supply Chain Quality. In addition, they will identify and facilitate the implementation of key capabilities at the site that will give the Quality team a competitive advantage. Plans, coordinates, and direct Quality control activities to ensure continuous production of products consistent with established quality & regulatory standards by performing the assigned duties and responsibilities to support manufacturing and timely delivery of product to customers. SECTION 2: DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: o Provides Management and Leadership in a laboratory environment. o Manages laboratory resources to ensure the appropriate level of support and prioritization for manufacturing activities and timely delivery of products to customers. o Ensures all laboratory activities are conducted in accordance with government regulations, safety requirements, Enterprise, Sector and Company policies. o Ensures the appropriate oversight and guidance for laboratory investigations including reviewing investigations to ensure that reports are consistent, complete and in alignment with applicable standards and procedures with appropriate content and references. o Ensures cGMP compliance in all aspects of the laboratory functions. o Ensures that all laboratory personnel have the required education and training to perform assigned job responsibilities. o Ensures all relevant core competency training modules are deployed to the laboratory personnel and that all laboratory procedures are aligned with the MD&D and Enterprise Laboratory Standards. o Ensures that laboratory equipment and systems are maintained in accordance with procedures and standards. o Ensures that validated/verified test methods and qualified and calibrated instruments are used for quality testing activities. o provides oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems. o Provides oversight of all Laboratory Quality Systems including Laboratory Change Management activities. o Provides oversight of Quality Agreements with Contract Laboratories to ensure excellent and appropriate communication between laboratories. Additionally, working with procurement to develop business agreements with Contract Laboratories. o Ensures Reviewing and approving technical protocols and reports to support validation/verification and qualification activities. o Ensures monitoring of laboratory metric trends on a regular basis and ensuring that appropriate investigation, corrective actions and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. o Provides audit support. o Leads /sponsors the implementation of improvement initiatives to address recurring laboratory issues. o Reviews and approves Quality Records (e.g. non-conformances, CAPA) related to laboratory events. o Maintaining knowledge of the regulatory trends related to relevant laboratory testing. o Communicating and elevating critical business related issues as well as opportunities to senior management. o Planning, promoting and organizing required training activities related to different laboratory testing areas. o Establishing and maintaining an annual operational budget. o Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices. Promoting Good Saves safety culture. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed. ❖ Compliance & Training Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any violation or deviation to the immediate supervisor or appropriate authority. Complies with all training requirements to perform duties of the job. Ensure adherence/compliance to Records Management policies and procedures, as applicable. ❖ Accountability: Maintains 5S states of laboratory, GLP & GMP in laboratory. Over all Laboratory accountability. Team building and credo. Laboratory metric & its review. Laboratory work as per current procedure and test method. Audit readiness within laboratory. 2.1 Authorities: Chemical test / Microbiological test Raw Data/Report review and approve (As applicable) Laboratory Log book Review Rejection note approval Lab Investigation Report, Lab incident approve (As applicable) PR/PO approval Internal and Cross functional document approval through applicable PLM/ADAPTIV system EtQ (NC , CAPA, audit observation, change request) approval OPEX/CAPEX finance related approvals Review / Approve Instrument Qualification/calibration/PM/AMC / validations /service reports/TMV documentation. Approve Outward/Inward Gate pass (as applicable) SECTION 3: EXPERIENCE AND EDUCATION* Graduate/Postgraduate/Ph.D in Science degree, preferably in a relevant scientific/technical field/ Pharmaceutical Sciences and 12 or more years of relevant experience in QMS environment. ( OR A minimum of 12 years responsibility and experience in a highly regulated environment is required including a broad and deep working knowledge of the operating functions of quality and compliance, supply chain, material supply and material handling and control, product manufacturing and product packaging. Minimum 5 years of experience in Supervisory or Managerial cadre.An understanding and application of cGMP and internal/external Health Authority compliance expectations is required. Excellent communication, collaboration, and influencing skills across multiple functions and levels within the organization is required. Prior experience with regulatory inspections is desirable. Prior experience with project management, Lean, Six Sigma, Operational Excellence, change management training and/or certification is desirable. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* Technical Skills / Behavioral Skills Functional competencies: Understanding of theory, and practical applications, of experimental techniques within a Quality lab, as well as key processes and activities, and the interdependencies and interactions with other functions. Conducting audits of in-house Quality labs and contract/external Quality labs. Technical understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards. Implementing innovative approaches to solving technical problems and troubleshooting, with limited guidance from management or other scientific personnel, while maintaining a high level of cGMP awareness. Professional Competencies Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management. Quality & Compliance: Quality Mindset, Compliance Orientation, Environment Health & Safety Business Fundamentals: Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation, Business Partnering: Influencing, Change Management, Time Management, Global Mindset & Management.
Posted 1 week ago
56.0 years
0 Lacs
Pune, Maharashtra, India
On-site
About Medline: About Medline India: Medline India was set up in 2010 in Pune, primarily as an offshore Development centre and to augment resources for Medline Industries LP, headquartered in Chicago, USA. We are a 1500+ strong and growing team of technology, finance & and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. We are proud to be certified as a ‘Great Place to Work’ by the Great Place to Work Institute® (India) for the duration of June 2025 – June 2026. We are an organisation with a conducive work environment, ample opportunities to learn, contribute and grow with a highly empowered & engaged team. We encourage our people to share their best ideas and create new opportunities for our customers and ourselves to work together to solve today’s toughest healthcare challenges. About Medline Industries, LP: Established in 1966, Medline Industries LP is a renowned global healthcare organisation boasting 56 years of consecutive sales growth, exceeding $21 billion in annual sales. With a workforce of over 36,000 professionals spread across the globe, we operate in more than 125 countries and territories. As the largest privately held manufacturer and distributor of medical supplies in the United States, Medline is uniquely positioned to offer comprehensive products, education, and support across the continuum of care. At present, Medline Industries, LP holds the esteemed position as the #1 market leader, delivering an extensive portfolio of over 550,000 medical products and clinical solutions. Our clientele includes hospitals, extended care facilities, surgery centres, physician offices, home care agencies, providers, and retailers. We're proud to be recognised by Forbes as one of America’s Best Large Employers and Best Employers for Women. Additionally, the Chicago Tribune has consistently named us a Top Workplace for the past 12 years. Job Description: Our Pune, India location currently has an exciting opportunity for a Quality Engineering Specialist within the Medline UNITE Foot and Ankle Orthopaedics Division. This role plays a key part in upholding quality standards aligned with our strategic engineering objectives. As a Quality Engineer, you will provide essential quality support across a range of activities, including complaint investigations, routine product evaluations, product testing, and documentation. You will also assist in vendor qualification processes. In addition to supporting ongoing QA functions, this position contributes to both new product development and legacy engineering projects related to implantable foot and ankle products and accessories. We are looking for someone who thrives in a team environment, demonstrates a strong sense of urgency, and can build and maintain effective working relationships with peers, customers, and suppliers. The role reports to the QRA Manager in India and the Quality Manager in the United States. Key Responsibilities, Responsible for validation activities, including evaluation of supplier documents (Physical, chemical & biological, packaging/transportation/ageing studies) for missing information/documents and development of biological evaluation plan & report. Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations and to support Design Control and Risk Management activities. Contribute to the construction and completion of DHFs, DMRs, Development & maintenance of product specification and other quality & regulatory documentation as necessary. Assist in customer/sales force complaints and ensure that complaints. Run monthly or quarterly complaint trend reports per SOP. Create and maintain inspection procedures. Work with the Regulatory team to provide supporting information for technical documentation. Ensure compliance with applicable testing requirements associated with product lines and processes. Additional Responsibilities Include, This position is responsible for maintaining quality levels and minimising defects and failure rates. Review of inspection reports if needed. Support Divisional Quality Engineers and Vigilance Teams on incidents (root cause analysis) and customer complaints investigation. Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Supplier Change Control, Quality Systems, Quality Audits, etc.). Must Have Degree or higher in B. Tech (Biomedical)/ B.E. (Mech)/ M. Pharm. (Quality Assurance). 5-to 7-year work experience within the Medical Device industry with a strong Quality background. Familiarity with 21 CFR Part 820 or ISO 13485 design requirements. Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards. Demonstrates excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders, ensuring alignment and understanding. Proficiency in MS Office (Word, Excel, PowerPoint, Outlook): Able to create and format professional documents, analyse and organise data, prepare clear presentations, and manage communication and scheduling effectively. Strong attention to detail and organisational skills: Ensures accuracy and compliance in data entry and documentation, maintains structured records, and manages multiple tasks efficiently. Demonstrates a strong focus on outcomes by setting clear goals, taking ownership, and consistently delivering high-quality results that align with business objectives. Good to Have Experience in working with orthopaedic or implantable devices/ systems. Working exposure in the US regulatory environment. Experience with ETQ Reliance, SAP, and QAD platforms. Exposure to global quality systems and multi-country document management. Ability to work independently and in a global team environment. Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards. Familiarity with CAPA management, Change management, and other quality activities. Working Hours: 10.30 am to 7.30 pm – daylight saving 11.30 am to 8.30 pm – non daylight saving
Posted 2 weeks ago
7.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
About the Company Newen Systems is India’s leading power conversion and energy storage solutions provider, driving energy transition and grid stability. Newen’s state of the art manufacturing facilities at Vadodara is at the heart of driving innovation and GW scale energy revolution for the world. With 3,000+ MW of battery storage deployed across 65+ countries in all seven continents, Newen Systems in technical collaboration with Dynapower is delivering BESS, Green H2, Microgrid and e-mobility infrastructure solutions to customers in India and around the world. Newen’s cutting edge energy management system is helping customers maximize their energy investment in ways it was not imagined earlier. Newen is uniquely positioned globally to provide EMS and PCS under one roof enabling customers to do integration tests within the factory rather than on site saving them time and money. As we expand, we are looking for intrapreneurial talent who have the passion to drive energy transition and deliver solutions to drive sustainability on a global scale. About the Role The Electrical Project Quality Engineer is responsible for ensuring that all electrical installations and systems meet the required quality standards and comply with applicable codes, standards, and project specifications. This role involves planning, implementing, and monitoring quality control procedures throughout the project lifecycle. Responsibilities Develop and implement project-specific Quality Plans, Inspection & Test Plans (ITPs), and checklists for electrical systems. Conduct inspections and tests on electrical installations including cable trays, wiring, panels, grounding, lighting, and control systems. Review and verify electrical drawings, specifications, and material submittals for compliance. Coordinate with construction teams, subcontractors, and suppliers to ensure quality standards are met. Monitor and document all quality control activities and maintain comprehensive records. Identify non-conformities, issue NCRs (Non-Conformance Reports), and ensure corrective actions are implemented. Participate in internal and external audits and support continuous improvement initiatives. Ensure compliance with safety regulations and electrical codes (e.g., NEC, IEC, IEEE). Provide technical support and training to site personnel on quality procedures and standards. Qualifications Bachelor’s degree in electrical/Electronic engineering or related field. Minimum 7 years of experience in electrical QA/QC roles within BESS or industrial projects. Strong knowledge of electrical systems, standards, and testing procedures. Excellent communication, documentation, and problem-solving skills. Required Skills Technical Skills: Electrical Engineering Knowledge: Strong understanding of electrical systems, components, and standards (e.g., IEC, NEC, IEEE). Quality Management Systems (QMS): Familiarity with ISO 9001 and other quality frameworks. Inspection & Testing: Proficiency in electrical testing methods (e.g., insulation resistance, continuity, voltage drop). Documentation & Reporting: Ability to prepare and manage ITPs, checklists, NCRs, and quality reports. Standards & Codes Compliance: Knowledge of national and international codes relevant to the project (e.g., MNRE, BIS for solar). Root Cause Analysis: Skills in identifying, analyzing, and resolving quality issues using tools like 5 Whys, Fishbone Diagram, etc. Analytical & Problem-Solving Skills: Attention to detail in identifying defects or deviations. Ability to interpret technical drawings and specifications. Strong troubleshooting skills for on-site quality issues. Tools & Software: MS Office Suite: Especially Excel and Word for documentation and reporting. AutoCAD / Electrical CAD: For reviewing and marking up drawings. Quality Management Software: Tools like SAP QM, ETQ, or custom project management platforms. Testing Equipment: Familiarity with multimeters, insulation testers, and other electrical QA tools.
Posted 3 weeks ago
4.0 - 7.0 years
0 Lacs
Gurugram, Haryana, India
On-site
Below are the roles and responsibilities: Quality Management System: Ensure & Support that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, preferably including ISO 13485, 21 CFR Part 820 (Current Good Manufacturing Practice (CGMP) regulations), and other standards. Proficient in understanding, review & align with relevant standard operating procedures as per the current technicalities with respect to QMS and other applicable regulatory requirements. Also ensure compliance of different functional QMS SOPs & Manuals. Proficient in Medical Device Labelling compliance (Including India Specific Requirements). Responsible for Execution of Actions for Nonconformance, CAPA, Change Management; Risk Evaluation and Impact assessment, Internal & External Audits / GAP Analysis (Surveys) – Existing SOP Surveys), Supplier Quality Management & Audits, Preparation and amendments of SOPs, Respective Training & Record Management, KPI Data Sourcing & details preparation for review meets. Understanding of Technical aspect and able to drive investigations in technical manner along with Technical department. Learn and Coordinate with Regional / Global Teams for relevant QMS procedures. Post Market Surveillance: Complaint Handling Process: Should be aware about the Indian guidelines for reporting AE/SAE complaints. Responsible for evaluation and assessment of any complaint/feedback from reporting point of view to authority. Responsible to support RA team to report the SAE/AE to CDSCO or its authorized centre. Recall and FCA Should be aware about the Indian and IMDRF countries guidelines about the Recall and FCA. Responsible for coordination with FSCA stakeholders, complaint assessment monitoring, and management of FSCA/Recall as per timeline and reporting of the same to CDSCO. Non-Conformity / CAPA Should be able to support activities towards reported non-conformities and prepare periodic reports, Hold NRBs and prepare NC details for meets, Learn and execute NC operations over Agile. CAPA management, learn Agile platform for CAPA operation. Hold CRB meets, monthly. Data Upkeepment / Training / Awareness Should be able to support QMS training & Awareness activities including data / record management. Should be able to timely prepare & upkeep key activities details for periodic reviews. Qualifications B. Tech / BME / – B. Pharma / M Pharma / M.Sc Biotechnology - Preferably with PG Diploma / QA and / or Preferred Certification (ISO13485 – Standard / Internal Auditor and/or LA and/or Risk Management (Medical Device) from reputed organization (such as TUV-SuD / BSI). Preferred Experience Minimum 4-7 years of working experience in a customer-oriented position in QA / QMS dept of an international organization, preferably the Medical Equipment / Device company. MS Office (focus Excel), Agile, Argus, etc. Fluent in oral/written communication (English). Preferable work experience on SFDC, EtQ, Track-Wise or Alike portal for execution of complaint initiation and handling. Interested candidates, please mail your resume to taru.arora@olympus.com. Regards HR Team
Posted 3 weeks ago
3.0 - 7.0 years
6 - 9 Lacs
Bengaluru
On-site
Job Description Understands and reviews requirements, creates test plans and/or contributes in test estimations, manual and automation planning/strategies Responsible for test case planning, authoring and execution of compliance products’ for client implementation projects Performs test iterations, defect tracking and reports test results; troubleshoots and coordinates with team focusing on defect resolution Collaborates with Developers, Tech Leads/Managers, BAs/Consultants and other project stakeholders throughout the SDLC Coordinates with BAs and development teams in troubleshooting and resolving road blocks and issues. Regularly documents, tracks and escalates issues and feedback as appropriate. Experience in running manual and automated test scripts and identifying scope for areas for automation. Proactively seeks necessary managerial support to discuss/flag risks and mitigation plans Optimum Skills or Background 3-7 years of experience in software testing field Excellent communication skills Proficient problem solving ability Familiarity with the software development life cycle (SDLC) Experience in writing clear, concise, and comprehensive test plans and test cases Attention to detail and strong analytical skills Bachelor’s degree in Computer Science or a related field Primary Skill Experience in Test case, Test Plan, Test strategies, Defect management, Estimation, RTM, SDLC Knowledge Good To have Exposure in Quality Management System like Track wise, ETQ Automation IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com
Posted 4 weeks ago
7.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
Job Title: Project Quality Engineer Locations: Pan India & Global Reporting: HOD About Newen Systems Newen Systems is India’s leading power conversion and energy storage solutions provider, driving energy transition and grid stability. Newen’s state of the art manufacturing facilities at Vadodara is at the heart of driving innovation and GW scale energy revolution for the world. With 3,000+ MW of battery storage deployed across 65+ countries in all seven continents, Newen Systems in technical collaboration with Dynapower is delivering BESS, Green H2, Microgrid and e-mobility infrastructure solutions to customers in India and around the world. Newen’s cutting edge energy management system is helping customers maximize their energy investment in ways it was not imagined earlier. Newen is uniquely positioned globally to provide EMS and PCS under one roof enabling customers to do integration tests within the factory rather than on site saving them time and money. As we expand, we are looking for intrapreneurial talent who have the passion to drive energy transition and deliver solutions to drive sustainability on a global scale. Job Summary: The Electrical Project Quality Engineer is responsible for ensuring that all electrical installations and systems meet the required quality standards and comply with applicable codes, standards, and project specifications. This role involves planning, implementing, and monitoring quality control procedures throughout the project lifecycle. Key Tasks: Develop and implement project-specific Quality Plans, Inspection & Test Plans (ITPs), and checklists for electrical systems. Conduct inspections and tests on electrical installations including cable trays, wiring, panels, grounding, lighting, and control systems. Review and verify electrical drawings, specifications, and material submittals for compliance. Coordinate with construction teams, subcontractors, and suppliers to ensure quality standards are met. Monitor and document all quality control activities and maintain comprehensive records. Identify non-conformities, issue NCRs (Non-Conformance Reports), and ensure corrective actions are implemented. Participate in internal and external audits and support continuous improvement initiatives. Ensure compliance with safety regulations and electrical codes (e.g., NEC, IEC, IEEE). Provide technical support and training to site personnel on quality procedures and standards. Skills: Technical Skills: Electrical Engineering Knowledge: Strong understanding of electrical systems, components, and standards (e.g., IEC, NEC, IEEE). Quality Management Systems (QMS): Familiarity with ISO 9001 and other quality frameworks. Inspection & Testing: Proficiency in electrical testing methods (e.g., insulation resistance, continuity, voltage drop). Documentation & Reporting: Ability to prepare and manage ITPs, checklists, NCRs, and quality reports. Standards & Codes Compliance: Knowledge of national and international codes relevant to the project (e.g., MNRE, BIS for solar). Root Cause Analysis: Skills in identifying, analyzing, and resolving quality issues using tools like 5 Whys, Fishbone Diagram, etc. Analytical & Problem-Solving Skills Attention to detail in identifying defects or deviations. Ability to interpret technical drawings and specifications. Strong troubleshooting skills for on-site quality issues Tools & Software MS Office Suite : Especially Excel and Word for documentation and reporting. AutoCAD / Electrical CAD : For reviewing and marking up drawings. Quality Management Software : Tools like SAP QM, ETQ, or custom project management platforms. Testing Equipment : Familiarity with multimeters, insulation testers, and other electrical QA tools. Qualifications & Experience: Bachelor’s degree in electrical/Electronic engineering or related field. Minimum 7 years of experience in electrical QA/QC roles within BESS or industrial projects. Strong knowledge of electrical systems, standards, and testing procedures. Excellent communication, documentation, and problem-solving skills.
Posted 1 month ago
0 years
7 - 10 Lacs
Chennai
On-site
Career Area: Engineering Job Description: Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do – but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here – we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Job Description: In this position, you will lead multi-functional groups that execute all phases of the NPI and RCCA for Medium Wheel Loaders. You will play a key role in leading light structure groups with a keen eye on the Quality, Time, and Cost of the program. This role will be expected to run multiple NPI programs at the same time and need to be involved in addressing the RCCA activities. You will be responsible for identifying and finding improvement opportunities that exist across Medium Wheel Loader light structure groups. Job Duties/Responsibilities: General As system/component design engineer, advise and answer engineering questions which comes from cross-functional team and customers, frequent collaboration with Supplier Development Engineer, Buyer, and Product support team. Prioritize workload and manage multiple projects simultaneously. Exhibit Excellent organizational, communication and presentation skills. Willing and able to collaborate with international teams in various time zones. Light Structures Design & detailing of Light structure systems (Conceptual development of components, assemblies, and groups). Experience in light structure design & detailing. Access and platform design Work on Creo (Sheet metal, Solid modelling, surface modelling, Top level assembly approach, Creo simulate etc) Responsible for all light structure system validation activities including analysis, test planning, and post-processing test data. Quality Provide engineering solutions to fix quality issues, such as field issues, carry-over analysis, NPI issues, production quality, CPI issues. Cost Provide solutions for component cost reduction and re-sourcing. Should cost modelling. Proficiencies/Capabilities: Innovate new ideas and leverage existing/new technology to drive cross-product synergy. In-depth understanding of the system and system interactions with the ability to make trade-offs at the machine level to avoid sub-optimization at the system level. Require limited direction but collaborate extensively with peers, clients, product team, suppliers, and other cross-functional teams Experience collaborating with suppliers to ensure manufacturing feasibility. Participated in a machine build/ machine validation test. Demonstrated experience in the following tools/methods: TC Workflow Creo Sheetmetal, Creo Surface, Creo Simulate Bolted Joint Analysis BIQ process Geometric Dimensioning and Tolerancing (GD&T) ETQ – Deviation/Advanced Product Quality Planning (APQP)/DFMEA Virtual Safety Audit Project Management NPI process/Structure/Gateway RCCA Use of Engineering Standards, Specifications, REDI Design Guides Basic Qualifications: Bachelor's degree from an Accredited College or University. Skill Descriptors Information Capture: Knowledge of the methods, channels and processes to obtain needed information; ability to identify, capture and document relevant business information in an auditable, organized, understandable and easily retrievable manner. Identifies information capture needs in own area. Describes key benefits, drawbacks and rationale for documenting relevant information. Provides examples of the risks associated with failing to record relevant information. Explains organizational methods for documenting, identifying and recording information. Standard Operating Procedures: Knowledge of established standard operating procedures (SOP); ability to design, implement and evaluate standard operating procedures affecting daily and strategic business operations in order to increase operational efficiency. Compiles current research relevant to standard operating procedures. Explains usage of standard operating procedures in business operations. Describes main issues and considerations when using standard operating procedures. Identifies key features and functions of standard operating procedures. Analytical Thinking: Knowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems. Names specific tools or techniques that can be used to support the analytical thinking process. Describes specific software applications or products used for business analytics. Gives examples of how analytical thinking has been used to resolve problems. Helps others research and learn more about business analytics tools and applications. Relocation is available for this position. Posting Dates: July 1, 2025 - July 10, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to apply? Join our Talent Community.
Posted 1 month ago
0 years
0 Lacs
Thane, Maharashtra, India
On-site
About us We are ALTANA: one group of companies – four divisions: BYK, ECKART, ELANTAS, and ACTEGA. A global leader in specialty chemicals and with myriad opportunities for you to develop and grow. Enrich your life with this decisive plus! With more than 8,000 employees, the ALTANA Group achieved sales of over 3 billion euros in 2024. BYK, as part of the ALTANA Group, is a leading global supplier of specialty chemicals. Our innovative and sustainable additives improve scratch resistance and surface gloss, the mechanical strength or flow behavior of materials, and properties such as UV and light stability or flame retardancy. BYK has been serving its customers in the Indian subcontinent region for more than 3 decades. BYK India Private Limited, incorporated in January 2018, has its registered office in Thane and corporate head office as well as ‘Customer Technology Centre’ in Pune. Executive – Supply Planning Location: Thane (Maharashtra) Responsibilities The main purpose of this role is to manage the end-to-end local manufacturing process ensuring the timely and accurate supply of raw material and packaging material to the manufacturing plant and finished goods to the central warehouse. He / she is responsible for sample supply planning by coordinating with counterparts in global locations. This includes collaborating with internal teams and external vendors to meet customer requirements while maintaining compliance with internal policies. The role also focuses on optimizing vendor performance and resolving topics proactively. Principal Accountabilities Locally manufactured products – supply management Coordinate with the sales team to understand customer demands and monitor seasonal impact to plan the inventory of finished goods in the warehouse Oversee the accuracy and timely arrival of imported raw materials with the help of the demand planner and logistics team Daily follow-up and weekly meetings with the manufacturing plant team to arrange the raw material and packing material on the requested date, post pre-shipment sample approval from the QC team Arrangement of vehicles to pick up the finished goods as per required timelines and communicate arrival status to the warehouse team with the set of dispatch documents to crosscheck the stock and post confirmation; get the GRN in SAP with the help of production report and dispatch documents Issue the daily status report Share the invoices of vendors with finance and release the payment as per due dates Resolve audit queries (if any) with respect to the overall process of locally manufactured goods Inventory management to avoid any potential loss of sale or excess inventory Manage complaints of vendors by using SAP and the complaint tool (ETQ) ensuring proper resolution on time Purchase Manage vendor relationships and obtain quotations from the approved vendors of raw material and packing material at desired frequencies, share the PO with vendors post-approval mentioning requested delivery date Track vendor performance, review KPIs, and ensure payment releases as per the due dates Assist in developing new vendors by following the company policy Responsible as “Process Owner” for ISO 9001:2015 for purchase Sample Planning Coordinate with customer service, technical team and sales team to generate the sample demand and manage the intercompany sample order by sea and air using SAP Maintain the dashboard and update the arrival of samples on time in India The key accountabilities are not necessarily complete and can be extended when needed. Requirements Graduate/Postgraduate or diploma holder in supply chain management from a recognized university / institute 8 plus years of firsthand professional experience in supply chain management, with a strong focus on supply planning and purchase, preferably in a specialty chemicals environment Proven ability to assess company needs, identify challenges, and provide effective solutions Strong customer advocacy with a customer-centric approach to service Excellent verbal and written communication skills, with the ability to effectively engage stakeholders at all levels Proficient in SAP, with experience in the SD, MM and Subcontracting modules Ability to work independently while also fostering strong team collaboration Cross-functional experience with a focus on problem-solving and delivering results, demonstrating flexibility and adaptability while collaborating with diverse teams Capability to act with urgency, quickly addressing roadblocks and capitalizing on opportunities Advanced user of Microsoft Office, including Word, Excel, and PowerPoint Our Plus In the ALTANA Group, you will work in a unique culture of innovation where the utmost importance is attached to promoting individual ideas and abilities as well as open, trusting interaction. At ALTANA we want to be leading in everything we do. Therefore, active implementation of ALTANA´s corporate culture in everyday life is the most effective guideline. Unshakable guidelines of ALTANA´s corporate culture are the four corporate values of ALTANA Appreciation Empowerment to act Openness and Trust They are the basis of the work at ALTANA, across divisions and continents, regions and countries, languages and cultural borders. Contact We invite you to get to know us better and to become part of our team. Discover your career plus in specialty chemistry. Please send us your application, preferably via our job market www.altana.jobs . For further information, please contact: Priya Gugale, priya.gugale@altana.com , +91 20 6719 0767 The closing date for all applications is 20th July 2025 and shortlisted candidates will be invited for a face-to-face interview. For further information on the company, visit our website at www.byk.com . ALTANA AG and its subsidiaries is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with disability. Job number: AW00309 Legal entity: BYK India Private Limited Location: Thane (Maharashtra)
Posted 1 month ago
0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
Career Area: Engineering Job Description: Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do – but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here – we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Job Description: In this position, you will lead multi-functional groups that execute all phases of the NPI and RCCA for Medium Wheel Loaders. You will play a key role in leading light structure groups with a keen eye on the Quality, Time, and Cost of the program. This role will be expected to run multiple NPI programs at the same time and need to be involved in addressing the RCCA activities. You will be responsible for identifying and finding improvement opportunities that exist across Medium Wheel Loader light structure groups. Job Duties/Responsibilities: General As system/component design engineer, advise and answer engineering questions which comes from cross-functional team and customers, frequent collaboration with Supplier Development Engineer, Buyer, and Product support team. Prioritize workload and manage multiple projects simultaneously. Exhibit Excellent organizational, communication and presentation skills. Willing and able to collaborate with international teams in various time zones. Light Structures Design & detailing of Light structure systems (Conceptual development of components, assemblies, and groups). Experience in light structure design & detailing. Access and platform design Work on Creo (Sheet metal, Solid modelling, surface modelling, Top level assembly approach, Creo simulate etc) Responsible for all light structure system validation activities including analysis, test planning, and post-processing test data. Quality Provide engineering solutions to fix quality issues, such as field issues, carry-over analysis, NPI issues, production quality, CPI issues. Cost Provide solutions for component cost reduction and re-sourcing. Should cost modelling. Proficiencies/Capabilities: Innovate new ideas and leverage existing/new technology to drive cross-product synergy. In-depth understanding of the system and system interactions with the ability to make trade-offs at the machine level to avoid sub-optimization at the system level. Require limited direction but collaborate extensively with peers, clients, product team, suppliers, and other cross-functional teams Experience collaborating with suppliers to ensure manufacturing feasibility. Participated in a machine build/ machine validation test. Demonstrated experience in the following tools/methods: TC Workflow Creo Sheetmetal, Creo Surface, Creo Simulate Bolted Joint Analysis BIQ process Geometric Dimensioning and Tolerancing (GD&T) ETQ – Deviation/Advanced Product Quality Planning (APQP)/DFMEA Virtual Safety Audit Project Management NPI process/Structure/Gateway RCCA Use of Engineering Standards, Specifications, REDI Design Guides Basic Qualifications: Bachelor's degree from an Accredited College or University. Skill Descriptors Information Capture: Knowledge of the methods, channels and processes to obtain needed information; ability to identify, capture and document relevant business information in an auditable, organized, understandable and easily retrievable manner. Identifies information capture needs in own area. Describes key benefits, drawbacks and rationale for documenting relevant information. Provides examples of the risks associated with failing to record relevant information. Explains organizational methods for documenting, identifying and recording information. Standard Operating Procedures: Knowledge of established standard operating procedures (SOP); ability to design, implement and evaluate standard operating procedures affecting daily and strategic business operations in order to increase operational efficiency. Compiles current research relevant to standard operating procedures. Explains usage of standard operating procedures in business operations. Describes main issues and considerations when using standard operating procedures. Identifies key features and functions of standard operating procedures. Analytical Thinking: Knowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems. Names specific tools or techniques that can be used to support the analytical thinking process. Describes specific software applications or products used for business analytics. Gives examples of how analytical thinking has been used to resolve problems. Helps others research and learn more about business analytics tools and applications. Relocation is available for this position. Posting Dates: July 1, 2025 - July 10, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to apply? Join our Talent Community.
Posted 1 month ago
10.0 - 15.0 years
0 Lacs
Mumbai Metropolitan Region
On-site
Date Posted: 2025-06-11 Country: India Location: Wester Region - 9th Floor, Magnus Tower, Mindspace, Link Road, Malad (West), MUMBAI-400064, India Job Profile: Senior Manager - FED Experience: Minimum 10-15 years in elevator/construction or related engineering field. Key Responsibilities: Technical Expertise: Must be technically sound in both electrical and mechanical aspects. Strong analytical and troubleshooting abilities Good communication and coordination skills Familiarity with elevator installation processes Proficiency in reading technical drawings and schematics Capable of troubleshooting any type of reported field issues independently. Coordination & Communication: Act as a key link between the field team and the factory team. Collect all field-reported issues and communicate them effectively to the factory for resolution. Ensure timely and efficient coordination for the implementation of solutions. FTB & System Handling: Responsible for uploading all Field Turn Back (FTB) cases into the ETQ system. Regular follow-up with the factory to track and close open FTBs. Drawing & Layout Interpretation: Should be capable of reading and understanding layout and technical drawings to assist in installation and issue diagnosis. Power Analyzer, Compass and PMT readings analyses: Familiarity with Ride quality adjustments and measuring tools. Analysis of PMT, Power Analyser readings is necessary. Extremely competent in handling EMS and Compass system Expert in chips level repairing. If you live in a city, chances are we will give you a lift or play a role in keeping you moving every day. Otis is the world’s leading elevator and escalator manufacturing, installation, and service company. We move 2 billion people every day and maintain approximately 2.2 million customer units worldwide, the industry's largest Service portfolio. You may recognize our products in some of the world’s most famous landmarks including the Eiffel Tower, Empire State Building, Burj Khalifa and the Petronas Twin Towers! We are 69,000 people strong, including engineers, digital technology experts, sales, and functional specialists, as well as factory and field technicians, all committed to meeting the diverse needs of our customers and passengers in more than 200 countries and territories worldwide. We are proud to be a diverse, global team with a proven legacy of innovation that continues to be the bedrock of a fast-moving, high-performance company. When you join Otis, you become part of an innovative global industry leader with a resilient business model. You’ll belong to a diverse, trusted, and caring community where your contributions, and the skills and capabilities you’ll gain working alongside the best and brightest, keep us connected and on the cutting edge. We provide opportunities, training, and resources, that build leadership and capabilities in Sales, Field, Engineering and Major Projects and our Employee Scholar Program is a notable point of pride, through which Otis sponsors colleagues to pursue degrees or certification programs. Today, our focus more than ever is on people. As a global, people-powered company, we put people – passengers, customers, and colleagues – at the center of everything we do. We are guided by our values that we call our Three Absolutes – prioritizing Safety, Ethics, Quality in all that we do. If you would like to learn more about environmental, social and governance (ESG) at Otis click here. Become a part of the Otis team and help us #Buildwhatsnext! Otis is An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other protected class according to applicable law. To request an accommodation in completing an employment application due to a special need or a disability, please contact us at careers@otis.com. Privacy Policy and Terms: Click on this link to read the Policy and Terms
Posted 1 month ago
2.0 years
0 Lacs
India
On-site
Responsibilities : Execute requirements gathering, elicitation, and development to capture and document business needs. Collaborate with developers and subject matter experts to establish the technical vision and analyse trade-offs between usability and performance needs Verify that the implemented changes are mapped to the user and functional requirements. Compose, edit, and produce documentation for existing and new developed applications/features. Implement changes into the product using Java, Python and SQL. Design high volume web services with complex business logic using RESTful and SOAP APIs to establish data interfaces. Requirements : Ability to work within a team environment and build relationships outside of the department as well as outside the company. Proven ability to direct, build, develop and manage a team of professionals. Ability to deal with difficult situations with tact, professionalism, and discretion. Demonstrate technical expertise and aggressiveness. Ability to work with minimum supervision and consider options to complete quality work. Proficient in personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, etc. Eligibility : Minimum of 2 years of hands-on experience with Python and SQL Educational qualification: B.Tech in Computer Science, BCA, or MCA Proficient in business communication, with excellent verbal and written English skills Prior knowledge of ETQ Script and ETQ Web Services would be a significant advantage
Posted 1 month ago
3.0 - 5.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Talent is hiring for one of its client. Job Description Responsibilities: Ensures efficient processing of custom and off the shelf direct materials purchase requisitions driven by a planning process in a manufacturing environment. Owns the assigned suppliers and parts for the timely delivery of materials to the manufacturing site to satisfy requirements for manufacturing and spare parts. Maintains effective collaboration with suppliers to ensure no disruption to manufacturing and escalates internally and externally for support as needed. Performs management of Supplier part lead times, safety stock, expedites, Supplier Change Notifications (SCNs) and supplier collaboration of delivery reschedules. Collaborates with Planning, Quality, Engineering, Manufacturing teams and Suppliers on material quality issues. May facilitate virtual meetings, publish notes / actions. Collaborates with Sourcing, used SAP material settings and executes purchase orders to optimize pricing tiers, minimum order quantities, supplier capacity plans. Coordinates with supplier, Quality and Warehousing on RMA return to vendor actions including repair and refurbishment. Works with a PLM (Product Lifecycle Management) system with access to specifications, part diagrams, work instructions, etc. Works with Reliance / ETQ quality management system, actions assignments, documents changes. Responsible for procurement business system data input and integrity, is champion for Suppliers using our Ariba B2B solutions, portals and collaboration tools. Ensures accuracy of confirmed delivery dates for materials on our SAP system and negotiates with suppliers as necessary to expedite or push out deliveries. Drives on time delivery, inventory turnover, requisition conversion and other key performance indicators (KPIs) for the assigned suppliers. Secures part certifications as appropriate from suppliers for successful global distribution of spare parts. May recommend cost saving proposals to suppliers in collaboration with Sourcing teams. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements: Experience in Global suppliers and stakeholder management SAP ECC MM module and MRP knowledge Ariba SCC knowledge preferred Thorough knowledge of direct procurement, vendor relations, and inventory management Familiar with GMP’s, product specifications incoming inspection procedures Effective verbal and written communication, analytical and interpersonal skills Strong problem solving, organizational skills, detail oriented. Strong influencing and negotiating skills Strong Knowledge of Microsoft Excel and Outlook required Willingness to work in shift to support US Region (No night shift required) All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Experience / Education: Typically requires a minimum of 3-5 years of related experience with a Bachelor’s degree; or 2 years and a Master’s degree; or a PhD without experience; or equivalent work experience
Posted 1 month ago
3.0 - 8.0 years
8 - 14 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A
Posted 1 month ago
7.0 years
0 Lacs
Vadodara, Gujarat, India
On-site
Job Title: Project Quality Engineer Locations: Pan India & Global Reporting: HOD About Newen Systems Newen Systems is India’s leading power conversion and energy storage solutions provider, driving energy transition and grid stability. Newen’s state of the art manufacturing facilities at Vadodara is at the heart of driving innovation and GW scale energy revolution for the world. With 3,000+ MW of battery storage deployed across 65+ countries in all seven continents, Newen Systems in technical collaboration with Dynapower is delivering BESS, Green H2, Microgrid and e-mobility infrastructure solutions to customers in India and around the world. Newen’s cutting edge energy management system is helping customers maximize their energy investment in ways it was not imagined earlier. Newen is uniquely positioned globally to provide EMS and PCS under one roof enabling customers to do integration tests within the factory rather than on site saving them time and money. As we expand, we are looking for intrapreneurial talent who have the passion to drive energy transition and deliver solutions to drive sustainability on a global scale. Job Summary: The Electrical Project Quality Engineer is responsible for ensuring that all electrical installations and systems meet the required quality standards and comply with applicable codes, standards, and project specifications. This role involves planning, implementing, and monitoring quality control procedures throughout the project lifecycle. Key Tasks: Develop and implement project-specific Quality Plans, Inspection & Test Plans (ITPs), and checklists for electrical systems. Conduct inspections and tests on electrical installations including cable trays, wiring, panels, grounding, lighting, and control systems. Review and verify electrical drawings, specifications, and material submittals for compliance. Coordinate with construction teams, subcontractors, and suppliers to ensure quality standards are met. Monitor and document all quality control activities and maintain comprehensive records. Identify non-conformities, issue NCRs (Non-Conformance Reports), and ensure corrective actions are implemented. Participate in internal and external audits and support continuous improvement initiatives. Ensure compliance with safety regulations and electrical codes (e.g., NEC, IEC, IEEE). Provide technical support and training to site personnel on quality procedures and standards. Skills: Technical Skills: Electrical Engineering Knowledge: Strong understanding of electrical systems, components, and standards (e.g., IEC, NEC, IEEE). Quality Management Systems (QMS): Familiarity with ISO 9001 and other quality frameworks. Inspection & Testing: Proficiency in electrical testing methods (e.g., insulation resistance, continuity, voltage drop). Documentation & Reporting: Ability to prepare and manage ITPs, checklists, NCRs, and quality reports. Standards & Codes Compliance: Knowledge of national and international codes relevant to the project (e.g., MNRE, BIS for solar). Root Cause Analysis: Skills in identifying, analyzing, and resolving quality issues using tools like 5 Whys, Fishbone Diagram, etc. Analytical & Problem-Solving Skills Attention to detail in identifying defects or deviations. Ability to interpret technical drawings and specifications. Strong troubleshooting skills for on-site quality issues Tools & Software MS Office Suite : Especially Excel and Word for documentation and reporting. AutoCAD / Electrical CAD : For reviewing and marking up drawings. Quality Management Software : Tools like SAP QM, ETQ, or custom project management platforms. Testing Equipment : Familiarity with multimeters, insulation testers, and other electrical QA tools. Qualifications & Experience: Bachelor’s degree in electrical/Electronic engineering or related field. Minimum 7 years of experience in electrical QA/QC roles within BESS or industrial projects. Strong knowledge of electrical systems, standards, and testing procedures. Excellent communication, documentation, and problem-solving skills.
Posted 1 month ago
150.0 years
0 Lacs
Pune, Maharashtra, India
On-site
Job Description You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you’ll help us deliver better care for billions of people around the world. It starts with YOU. In This Role, You Will As a Senior Quality Engineer at the Pune Plant, you will report directly to the Quality Manager. In this role, you will be responsible for conducting routine quality checks in accordance with Kimberly-Clark’s quality guidelines and ensuring full compliance with all applicable regulatory requirements from a quality perspective. You will also support activities related to Quality Management System (QMS) compliance and continuous improvement. Additionally, you will be involved in the deployment of global and segment-level quality initiatives, standards, and tools. A key part of your responsibilities will be strong quality mindset within the team. you will be expected to drive and embed the quality agenda across all plant operations. Drive RFT Performance across the value chain (Procure, Make, Move, Sell) to ensure quality from sourcing to delivery. Ensure Compliance with Kimberly-Clark’s QMS, regulatory standards, and product category requirements (BCC, AFC). Lead Quality Investigations, including RCA and CAPA, ensuring timely and effective resolution of incidents. Manage Change Controls by leading risk assessments (FMEA) and coordinating quality input for trials, product changes, and new initiatives. Collaborate with Suppliers to resolve quality issues and ensure compliance with standards. Coordinate QA Activities with internal stakeholders during product and process changes. Support Continuous Improvement through data analysis and quality improvement projects. Conduct Training on GMP, hygiene, product safety, and quality tools to build team capability. Manage Customer Feedback by cascading complaints and promoting problem-solving at the shop floor level. Maintain QA Systems including non-conformance reporting, PASS data, EtQ protocols, and lab/tester certifications. Benchmark & Implement Best Practices by collaborating with other KC sites. About Us Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn’t exist without talented professionals, like you. At Kimberly-Clark, you’ll be part of the best team committed to driving innovation, growth and impact. We’re founded on more than 150 years of market leadership, and we’re always looking for new and better ways to perform – so there’s your open door of opportunity. It’s all here for you at Kimberly-Clark. Led by Purpose. Driven by You About You You perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we’re constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you’ll experience Flex That Works: flexible work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business. Key Qualifications And Experiences In one of our technical roles, you’ll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center. To succeed in this role, you will need the following qualifications: Minimum Graduate in Engineering/Postgraduate in Science. Minimum 4-5 year of experience in manufacturing function. Ability to work effectively with computer systems and a thorough knowledge of current office practices and procedures. Proficiency in Microsoft applications such as Outlook, Teams, Excel, Word, PowerPoint. High resilience and energy in a fast paced and changing environment Good listening ability Ability to win with limited resources Ability to work collaboratively and to develop a collaborative winning mindset. Analytical capability, and able to make quick decisions to solve issues Ability to work as a team player Demonstrated ability to work with cross functional teams effectively. To Be Considered Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role. In the meantime, please check out the careers website. And finally, the fine print…. For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position. Employment is subject to verification of pre-screening tests, which may include drug screening, background check, and DMV check. Primary Location Pune Sanaswadi Mill Additional Locations Worker Type Employee Worker Sub-Type Regular Time Type Full time Show more Show less
Posted 1 month ago
3.0 - 5.0 years
0 Lacs
Greater Bengaluru Area
On-site
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Responsibilities Ensures efficient processing of custom and off the shelf direct materials purchase requisitions driven by a planning process in a manufacturing environment. Owns the assigned suppliers and parts for the timely delivery of materials to the manufacturing site to satisfy requirements for manufacturing and spare parts. Maintains effective collaboration with suppliers to ensure no disruption to Illumina manufacturing and escalates internally and externally for support as needed. Performs management of Supplier part lead times, safety stock, expedites, Supplier Change Notifications (SCNs) and supplier collaboration of delivery reschedules. Collaborates with Planning, Quality, Engineering, Manufacturing teams and Suppliers on material quality issues. May facilitate virtual meetings, publish notes/actions. Collaborates with Sourcing, used SAP material settings and executes purchase orders to optimize pricing tiers, minimum order quantities, supplier capacity plans. Coordinates with supplier, Quality and Warehousing on RMA return to vendor actions including repair and refurbishment. Works with a PLM (Product Lifecycle Management) system with access to specifications, part diagrams, work instructions, etc.. Works with Reliance / ETQ quality management system, actions assignments, documents changes. Responsible for procurement business system data input and integrity, is champion for Suppliers using our Ariba B2B solutions, portals and collaboration tools. Ensures accuracy of confirmed delivery dates for materials on our SAP system and negotiates with suppliers as necessary to expedite or push out deliveries. Drives on time delivery, inventory turnover, requisition conversion and other key performance indicators (KPIs) for the assigned suppliers. Secures part certifications as appropriate from suppliers for successful global distribution of spare parts. May recommend cost saving proposals to suppliers in collaboration with Sourcing teams. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements Experience in Global suppliers and stakeholder management SAP ECC MM module and MRP knowledge Ariba SCC knowledge preferred Thorough knowledge of direct procurement, vendor relations, and inventory management Familiar with GMP’s, product specifications incoming inspection procedures Effective verbal and written communication, analytical and interpersonal skills Strong problem solving, organizational skills, detail oriented. Strong influencing and negotiating skills Strong Knowledge of Microsoft Excel and Outlook required Willingness to work in shift to support US Region (No night shift required) All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Experience/Education Typically requires a minimum of 3-5 years of related experience with a Bachelor’s degree; or 2 years and a Master’s degree; or a PhD without experience; or equivalent work experience Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship. Show more Show less
Posted 1 month ago
10.0 - 12.0 years
0 Lacs
Aurangabad, Maharashtra, India
On-site
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function Supply Chain Engineering Job Sub Function Manufacturing Engineering Job Category Scientific/Technology All Job Posting Locations: Aurangabad, Maharashtra, India Job Description SECTION 1: JOB SUMMARY* Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations. Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization. Responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects and regular maintenance. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team. Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects. Is responsible for the Process Safety Management activities for the site. SECTION 2: DUTIES & RESPONSIBILITIES* Ensures coordination and execution of the recurring validation activities according to validation master plan. Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues. Establishes and communicates process and program schedules, objectives, priorities, and targets. Ensures the documentation of project and program activities and deliverables. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects. Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis. Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean). Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project. Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project. Ensuring process optimization within the stabilization phase of a assigned project Engages to comply with ISO and FDA requirements. Ensuring compliance to the Quality system requirements. Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision. Assuring that engineering department is appropriately run in a safe, clean, and environmentally sound manner. Developing and analyzing statistical data and machine specification to determine present standards and establish proposed quality and reliability expectancy of finished product. Assisting in engineering budget preparation, goal tracking and in the business planning process. Supporting for NCR’s investigation and performs trend analysis and report to Management. Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training. Participating in audits and gap assessments in support of the internal audit program and FDA readiness. Partnering with operations in the investigation / correction of process failure Developing safety culture in the engineering function. Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end. Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR). Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work. Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives. Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them. Lead the various sterilization related projects in tandem with WW sterilization experts. Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development. Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria. Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc. required for manufacturing /Sterilization/UDI/Serialization & as required. AUTHORITIES Create PR in emp/Ariba. Create & Approve PR in emp/Ariba Create/Approve Gate Pass for material. Change Assessment creation in ADAPTIV/ PLM system. CO/CP creation in ADAPTIV/PLM system. QMS document Approval creation/Approval in ADAPTIV/ PLM system. SECTION 3: EXPERIENCE AND EDUCATION* Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream). Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling. Demonstrated knowledge of manufacturing principles and practices and procedures. Knowledge of specific business practices and software and software applications. Experience using medical device equipment. Ability to communicate effectively with a diverse client/stakeholder base. Ability to work cooperatively with coworkers, peers and required stakeholders. Ability to perform duties in accordance with policies and procedures. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional Competencies - Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives. Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas. Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives. Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to develop/plan qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Professional Competencies- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues, and provide well-reasoned conclusions and solutions. Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes. Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance- related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements. Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions. Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures. Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line. Knowledge of project management methodologies (e.g., PMP etc.) Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas. Knowledge of SAP based MRP, Visio, MS Project, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire. Show more Show less
Posted 1 month ago
0.0 - 12.0 years
0 Lacs
Aurangabad, Maharashtra
On-site
Function Supply Chain Engineering Sub function Manufacturing Engineering Category Senior Engineer, Manufacturing Engineering (ST6) Location Aurangabad / India Date posted Jun 16 2025 Requisition number R-016531 Work pattern Fully Onsite Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Aurangabad, Maharashtra, India Job Description: SECTION 1: JOB SUMMARY* Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations. Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization. Responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects and regular maintenance. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team. Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects. Is responsible for the Process Safety Management activities for the site. SECTION 2: DUTIES & RESPONSIBILITIES* Ensures coordination and execution of the recurring validation activities according to validation master plan. Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues. Establishes and communicates process and program schedules, objectives, priorities, and targets. Ensures the documentation of project and program activities and deliverables. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects. Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis. Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean). Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project. Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project. Ensuring process optimization within the stabilization phase of a assigned project Engages to comply with ISO and FDA requirements. Ensuring compliance to the Quality system requirements. Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision. Assuring that engineering department is appropriately run in a safe, clean, and environmentally sound manner. Developing and analyzing statistical data and machine specification to determine present standards and establish proposed quality and reliability expectancy of finished product. Assisting in engineering budget preparation, goal tracking and in the business planning process. Supporting for NCR’s investigation and performs trend analysis and report to Management. Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training. Participating in audits and gap assessments in support of the internal audit program and FDA readiness. Partnering with operations in the investigation / correction of process failure Developing safety culture in the engineering function. Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end. Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR). Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work. Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives. Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them. Lead the various sterilization related projects in tandem with WW sterilization experts. Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development. Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria. Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc. required for manufacturing /Sterilization/UDI/Serialization & as required. AUTHORITIES Create PR in emp/Ariba. Create & Approve PR in emp/Ariba Create/Approve Gate Pass for material. Change Assessment creation in ADAPTIV/ PLM system. CO/CP creation in ADAPTIV/PLM system. QMS document Approval creation/Approval in ADAPTIV/ PLM system. SECTION 3: EXPERIENCE AND EDUCATION* Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream). Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling. Demonstrated knowledge of manufacturing principles and practices and procedures. Knowledge of specific business practices and software and software applications. Experience using medical device equipment. Ability to communicate effectively with a diverse client/stakeholder base. Ability to work cooperatively with coworkers, peers and required stakeholders. Ability to perform duties in accordance with policies and procedures. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional Competencies - Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives. Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas. Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives. Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to develop/plan qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Professional Competencies- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues, and provide well-reasoned conclusions and solutions. Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes. Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance- related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements. Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions. Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures. Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line. Knowledge of project management methodologies (e.g., PMP etc.) Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas. Knowledge of SAP based MRP, Visio, MS Project, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire.
Posted 1 month ago
0.0 - 12.0 years
0 Lacs
Aurangabad, Maharashtra
On-site
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Aurangabad, Maharashtra, India Job Description: SECTION 1: JOB SUMMARY* Design, execution and documentation of process characterization, process development, equipment qualification, validations, Manufacturing Equipment and Sterilization Validation Master Plan, and test methods used in manufacturing processes in the context of the applicable standards and regulations. Lead- Process Engineering is responsible to execute process engineering deliverables as per the engineering and base business strategies and objectives at the Aurangabad site. Ensures flawless execution of Manufacturing process validations or qualifications. Provides leadership to the Process team and ensures the support from all engineering functions and also other required cross functions. Responsible to ensure the integration with the regional and WW process engineering organization. Responsible to develop and execute the Sterilization strategies and objectives at ETHICON, Aurangabad site. Provides the leadership & support to engineering function for execution of EO and GAMMA sterilization projects and regular maintenance. Provide Technical knowledge to the Manufacturing engineering, Process engineering and Engineering Projects team. Designs, develops, tests, and evaluates new and existing manufacturing systems for industrial production processes including human work factors, material flow, cost analysis, and process optimization in both production and packaging operations which includes but not limited to Technology Roadmap projects. Is responsible for the Process Safety Management activities for the site. SECTION 2: DUTIES & RESPONSIBILITIES* Ensures coordination and execution of the recurring validation activities according to validation master plan. Leads cross functional teams (internal and external to engineering) and resolves inter- functional issues. Establishes and communicates process and program schedules, objectives, priorities, and targets. Ensures the documentation of project and program activities and deliverables. Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities. Training of employees in validation specifications, test plans, test methods, etc. Supporting the selection of processes / machines, taking into account the requirements of project and production as well as investment and cost aspects. Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis. Developing manufacturing processes under application / taking into account methodological concepts (Six Sigma, Lean). Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project. Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project. Ensuring process optimization within the stabilization phase of a assigned project Engages to comply with ISO and FDA requirements. Ensuring compliance to the Quality system requirements. Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision. Assuring that engineering department is appropriately run in a safe, clean, and environmentally sound manner. Developing and analyzing statistical data and machine specification to determine present standards and establish proposed quality and reliability expectancy of finished product. Assisting in engineering budget preparation, goal tracking and in the business planning process. Supporting for NCR’s investigation and performs trend analysis and report to Management. Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training. Participating in audits and gap assessments in support of the internal audit program and FDA readiness. Partnering with operations in the investigation / correction of process failure Developing safety culture in the engineering function. Prepares capital expenditure proposals starting from preparation of draft proposals, vendor selection, price negotiations, planning, and execution. Leads projects end-to-end. Lead engineering projects, New Technology or Technology Transfer projects to improve existing technology with respect to Quality, Compliance, Capacity and Cost. Ensure that projects are completed on time and within budget with no impact to quality or customer service. Develop and execute detailed project plans using standard project management tools (charter, Gantt chart, etc.). Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR). Sterilization: Under limited supervision & general direction and in accordance with all applicable federal, state and local laws/ regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Prioritize, assign and coordinate for EO & Gamma sterilization, UDI, serialization and related work. Establish, review and communicate plans (work/project scope, cost, schedule, resource requirements, and risks) for sterilization related activities required to meet system demands and business objectives. Lead & prepare a sterilization road map and prepare a strategy to implement them. Support in preparing technology road map and prepare a strategy to implement them. Lead the various sterilization related projects in tandem with WW sterilization experts. Lead & deliver projects like sterilizer replacement, new cycle creation, existing cycle improvement (as needed) and new practices development. Monitor progress to ensure final deliverable meet lifecycle boundaries and customer acceptance criteria. Engage to comply with ISO and local FDA requirements. Responsible for revision I creation of documents like SOP, Forms etc. required for manufacturing /Sterilization/UDI/Serialization & as required. AUTHORITIES Create PR in emp/Ariba. Create & Approve PR in emp/Ariba Create/Approve Gate Pass for material. Change Assessment creation in ADAPTIV/ PLM system. CO/CP creation in ADAPTIV/PLM system. QMS document Approval creation/Approval in ADAPTIV/ PLM system. SECTION 3: EXPERIENCE AND EDUCATION* Bachelor’s degree with minimum 10 to 12 years of experience in Engineering/Industrial/Electrical/Mechanical Engineering (related stream). Experience in the Medical Device industry or pharmaceutical or consumer or similar industry with experience in aseptic handling. Demonstrated knowledge of manufacturing principles and practices and procedures. Knowledge of specific business practices and software and software applications. Experience using medical device equipment. Ability to communicate effectively with a diverse client/stakeholder base. Ability to work cooperatively with coworkers, peers and required stakeholders. Ability to perform duties in accordance with policies and procedures. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Functional Competencies - Engineering Basics: Ability to use knowledge of technical designs, Understanding and creating Engineering drawings and leads key site projects/base business automation initiatives. Manufacturing processes Knowledge: Displays in-depth knowledge of manufacturing methods and standards of process control. Leverages the knowledge and leads practices to implement sustainable process improvements in assigned areas. Product knowledge: Understanding of Product functionalities and identifies improvement opportunities. Understand product requirements and translate into product characteristics and procedures. Ability to define, measure, improve product characteristics and their co-relation with product performance. Process Excellence: Displays in-depth understanding of Lean tools & techniques, Value stream mapping, Six Sigma as a certified Black Belt, Statistical Data Analysis & process controls. Technical Quality and Compliance: Displays in-depth knowledge of J&J quality standards to implement cross-functional corrective action related to quality issues. Use in-depth knowledge of EHS policies to guide others when implementing EHS initiatives. Standard Cost generation: Displays in-depth Knowledge within Financial Systems and Budget Preparation, ROI calculation, standard cost planning and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Image/Signal Processing and Robotics: Displays in-depth Knowledge within image analysis, image processing, image algorithms, robotic systems, software and verification systems development and leverages the skills and leading Practices to implement processing strategy. Mechanical Equipment & Systems: Displays in-depth knowledge of commissioning of mechanical equipment, Safety equipment and leverages best practices. Process Validations: Ability to develop/plan qualification strategy for overall process, execution of strategy and plans in a diligent manner; ability to react/resolve issues that occur during qualifications; basic knowledge of statistical techniques. Packaging Equipment and Operation: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Automation & Robotics, Vacuum Technology, Programmable Logic Controllers (PLC), Mechanical Engineering, Sterilization/Cleanroom Technology. Packaging Process: Consistently applies Knowledge and experience to a wide variety of activities and situations associated with Packaging Process, Packaging Materials, Test Methods, Packaging Classification & Types. Packaging Design: Displays in-depth Knowledge within Develops & Implements New Technology concepts and methods and leverages the skills and leading Practices to implement long range business plans that meet J&J strategic Goals & creates new opportunities. Professional Competencies- Analytical Problem Solving: Applies understanding of analytic techniques to interpret data, identify issues, analyze causes of the issues, and provide well-reasoned conclusions and solutions. Technology & Data Management: Uses in-depth knowledge of system and technology capabilities, architecture, and leading practices to effectively interface with IT professionals to identify, select, and implement tools that enable business processes. Quality Mindset: Participates in quality processes, as appropriate, including validation and compliance- related issues (for example, FDA regulations, holds, customs, etc.) Demonstrates an understanding of the critical importance of traceability and ability to apply supporting approaches or technologies (i.e. lot coding, expiration dating, etc.) Applies knowledge of validation strategies and/or continuous improvement concepts to proactively identify process deficiencies or improvements. Analytical Problem solving: Uses in-depth knowledge of analysis and problem-solving techniques to study reports, identify underlying issues or trends, and assess broader implications of the findings, based upon the interpretation of quantifiable data, to recommend appropriate solutions. Project Management: Demonstrates expertise in project management tools and techniques, interactions with project stakeholders and sponsors. Identifies innovative ways to improve cost or lead-time to maximize resources to achieve project outcomes. Leverages understanding of FPX and other project management methodologies to perform root-cause analysis on project failures. Business Case Development: Uses in-depth knowledge of business case development to articulate the business case for broad, cross-departmental change to decision-makers Mentors others by providing direction and context for change by outlining linkages between functional activities and J&J’s bottom line. Knowledge of project management methodologies (e.g., PMP etc.) Knowledge of continuous improvement tools, Lean Manufacturing & Six- Sigma. Ability to lead a team of professionals with diverse skills and competencies spanning business & technical areas. Knowledge of SAP based MRP, Visio, MS Project, Minitab, ADAPTIV, ETQ Audit, ETQ CAPA, ETQ NC & Compliance Wire.
Posted 1 month ago
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