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6.0 - 10.0 years

10 - 20 Lacs

Nagpur, Nashik, Pune

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Review & approval of manufacturing quality assurance plans. Inspection of products at vendor factory. Assessment of new vendors. Interaction with customers for approval of documents. Product failure analysis.Must have exp in Solar/ power Projects. Required Candidate profile Exp in quality assurance, preferably in the substation or power industry.Exp in quality management systems. Familiarity with industry standards. Exp with substation design, manufacturing, or testing.

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10.0 - 16.0 years

40 - 50 Lacs

Bengaluru

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As part of the Merchant Reporting & Insights team at PayPal, you will lead the development of mission-critical systems that ingest, orchestrate, and analyze massive volumes of data. These systems generate millions of high-volume reports, transforming complex fintech data into actionable business insights. you'll be responsible for ensuring timely delivery of reports aligned with merchant SLAs and business cadences. Meet our team The Merchant Reporting & Insights team is at the heart of PayPal s data-driven decision-making. We build scalable data platforms and reporting tools that empower merchants with real-time insights. you'll collaborate with cross-functional teams across engineering, product , customers to deliver impactful solutions that drive business outcomes. Your way to impact You will lead the design and development of scalable, enterprise-grade data solutions that power critical reporting for merchants globally. Your leadership will drive innovation in big data and real-time processing, ensuring high-throughput systems meet business needs. you'll foster a culture of technical excellence, collaboration, and continuous improvement. Your Day-to-Day: Provide technical leadership and guidance to teams of software engineers, fostering a culture of collaboration, innovation, and continuous improvement. Establish outcomes and key results (OKRs) and successfully deliver them. Drive improvements in key performance indicators (KPIs). Increase the productivity and velocity of delivery teams. Develop, plan, and execute engineering roadmaps that bring value and quality to our customers. Collaborate and coordinate across teams and functions to ensure technical, product, and business objectives are met. Instill end-to-end ownership of products, projects, features, modules, and services that you and your team deliver in all phases of the software development lifecycle. What do you need to bring: 10+ years of experience in the software industry, with 3+ years of professional experience leading software development teams. Strong critical thinking and problem-solving skills with the ability to address complex technical and non-technical challenges. Experience building and developing engineering teams that exhibit strong ownership, user empathy, and engineering excellence. Proven track record of delivering high-quality systems and software in Big Data Technologies including Spark, Airflow, Hive, etc, with practical exposure to integrating machine learning workflows into data pipelines. Proven track record of delivering high-quality systems and software in Java/J2EE technologies and distributed systems, with experience deploying ML models into production at scale using REST APIs, streaming platforms, or batch inference. Excellent communication skills with the ability to collaborate effectively with cross-functional teams (including data scientists and ML engineers) and manage stakeholders expectations. Ability to coach and mentor talent to reach their full potential, including guiding teams in adopting MLOps best practices and understanding AI model lifecycle management. Experience in building large scale, high throughput, low latency systems, including real-time data processing systems that support personalization, anomaly detection, or predictive analytics. Strong understanding of software development methodologies, modern technology topics and frameworks, and developer operations best practices. Experience with ML platforms (eg, Kubeflow, MLflow) and familiarity with model monitoring, feature engineering, and data versioning tools is a plus. Provide leadership to others, particularly junior engineers who work on the same team or related product features. Proven experience delivering complex software projects and solutions effectively through Agile methodologies on a regular release cadence. Strong verbal and written communication skills. Strong customer focus, ownership, urgency and drive.

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3.0 - 8.0 years

25 - 30 Lacs

Bengaluru

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We are the guardians of the Amazon galaxy. The Account Compliance team strives to ensure that Amazon remains compliant and the cost of being compliant is never the reason where the business or our sellers cannot scale. Our diverse team innovates on behalf of their customers to build a trusted marketplace through best-in-class compliance products. With hundreds of millions of customers around the world depending on our products & services, our systems form the tip of the spear against bad actors. These actors might abuse Amazon products and undermine customer faith, so our success comes from identifying & removing them while delivering best-in-class customer experiences for the good actors and strategic customers. we're creating the most trusted store on earth, enabling Amazon to innovate at scale, and supporting our customers to launch & grow their business faster than anywhere else in the world. As a Software Development Engineer in the account compliance team, you will design and build software that 1) is extensible to different use cases, products, and geographies with almost zero incremental tech effort, 2) can trigger verifications that are necessary under applicable policies, 3) can store verification decisions for re-use to reduce duplicative checks; and (5) is vendible to any authorized user via API. The software is smarter than the smartest bad actors in the world to protect the store from illegal activities at scale. Amazons scale means that you'll be designing and developing custom distributed systems more advanced than those used in standard industry practices. These data-centric systems need to detect patterns across Amazons huge customer population as they happen and be adaptive so that they can detect new modus operandi as they develop. Lastly, they need to be highly available, low latency, high quality systems. If this sounds interesting to you, then apply and find out more 3+ years of non-internship professional software development experience 2+ years of non-internship design or architecture (design patterns, reliability and scaling) of new and existing systems experience Experience programming with at least one software programming language 3+ years of full software development life cycle, including coding standards, code reviews, source control management, build processes, testing, and operations experience Bachelors degree in computer science or equivalent

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3.0 - 8.0 years

7 - 8 Lacs

Bengaluru

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This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site lead, the Quality Control Analyst is responsible for managing the day today activities quality control function at Cepheid India Private Ltd. Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements. In this role, you will have the opportunity to: Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs). Competent technical staff for supervision the Testing/ analysis of diagnostic reagents & kits. Perform inspections of incoming, in-process and finished products. Performs and calibration and maintenance of lab equipment as per requirements. May perform special projects on analytical and instrument problem solving. Ensure that lab cleanliness and safety standards are maintained. Qualify test methods as part of new product development activities. Serve as a technical liaison between quality control and other departments Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses & Write or revise standard quality control operating procedures. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines. Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Review records and documents for completeness and compliance with company policies and procedures. Support for internal audit schedule, NC, CAPA for site. Review production batch records, QC test results and release product. Education and Experience: masters degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years experience with in Vitro Diagnostics (IVD) is mandate Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable Quality competent technical person approved as per D&C act if any Knowledge and skills: Hands on Experience on IVD product testing. Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS. Must be flexible to work off-shifts and weekends as per production Schedule. Schedule orientated (able to consistently maintains schedules and meet timelines) Strong interpersonal skills, Effective organization and Communication skills are essential. Good skills in English language Knowledge of Microsoft Word and Excel Strong multi-tasking and attention to details skills. It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Able to interpret quality problem and establish practical solutions within a dynamic business environment. Experience in leading continuous improvement efforts, in both quality systems and products. Knowledge of the process of establishing facility QMS certifications. Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable

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2.0 - 5.0 years

5 - 8 Lacs

Bengaluru

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This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site lead, the Quality Control Analyst is responsible for managing the day today activities quality control function at Cepheid India Private Ltd. Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements. In this role, you will have the opportunity to: Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs). Competent technical staff for supervision the Testing/ analysis of diagnostic reagents kits. Perform inspections of incoming, in-process and finished products. Performs and calibration and maintenance of lab equipment as per requirements. May perform special projects on analytical and instrument problem solving. Ensure that lab cleanliness and safety standards are maintained. Qualify test methods as part of new product development activities. Serve as a technical liaison between quality control and other departments Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses Write or revise standard quality control operating procedures. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines. Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Review records and documents for completeness and compliance with company policies and procedures. Support for internal audit schedule, NC, CAPA for site. Review production batch records, QC test results and release product. Education and Experience: masters degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years experience with in Vitro Diagnostics (IVD) is mandate Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable Quality competent technical person approved as per DC act if any Knowledge and skills: Hands on Experience on IVD product testing. Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS. Must be flexible to work off-shifts and weekends as per production Schedule. Schedule orientated (able to consistently maintains schedules and meet timelines) Strong interpersonal skills, Effective organization and Communication skills are essential. Good skills in English language Knowledge of Microsoft Word and Excel Strong multi-tasking and attention to details skills. It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Able to interpret quality problem and establish practical solutions within a dynamic business environment. Experience in leading continuous improvement efforts, in both quality systems and products. Knowledge of the process of establishing facility QMS certifications. Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable.

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0.0 - 2.0 years

2 - 4 Lacs

Mumbai

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Planit are world leaders in application testing and quality engineering. We provide solutions that support organisations to deliver high quality systems, applications, and IT architecture. Planit is now a proud NRI company and part of a global movement to deliver a sustainable and secure future through better Information Technology exchanges. Our team offer expert consultancy, bespoke services, tailored training and unique solutions to complex projects. Specialising in digital quality, Planit have a geographic footprint across many continents, with 1700+ permanent employees and have been recognised in Gartners Magic Quadrant for Application Testing Services. Our values and ethos are focused on an intrinsic connection to our people, the awareness of our environment and our pursuit to be better than yesterday. We continue to lead the industry with unrivalled ideas, ability, and a quest to discern paradigms About the role: The role demands here that the candidate should have working experience into Functional testing (i.e. to create the test cases, test scenarios, detect bugs). Along with this, stakeholder management, client interaction, and leadership qualities are an added advantage. Responsibilities : 0- 2 years of experience. Bachelors degree in computer science or equivalent field. Excellent Communication skills. Excellent Analytical & problem-solving skills.. knowledge of Software Testing . Knowledge of any programming Language (Java/ Python). Skills & Experience: 0 - 2 years of experience in Manual Testing Culture and Benefits: For the right person we will provide:- A competitive remuneration package with career pathways within our talent team as we continue to expand globally An open, flexible hybrid working environment where you can immediately see the impact of your work and delivery towards the business success All of the tools, software and support you need (we ve just undergone a migration of our ATS platform with bleeding edge tool /process to enable success) Benefits including health insurance, Free LinkedIn Learning licences, Training platforms & internet reimbursement among others.

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3.0 - 5.0 years

5 - 7 Lacs

Pune

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Your Role Job Description/Mission Your primary role is to be a vital member of the team and a main point of contact for customer projects. Your mission is to contribute to product management activities from an engineering perspective, while also enhancing the technical proficiency of the GECIA team with a solution-oriented mindset. To accomplish this, you will need to continually improve your own skillset and familiarize yourself with the latest technology platforms. Additionally, you will be responsible for ensuring on-time delivery and a first-time right approach in all your work. Key Responsibilities Customer Focus - Study & Analyse Technical Specifications for Scope, Technical requirements and work content based on the inputs received. - Generate 3D layouts, detail engineering and drawings for new deigns, Customised/ES Piston products and Skid Packages. - Monitor performance parameter like Timely completion, Quality of drawings and First time right. - Generating necessary documents for task as per SOP s and Quality Systems. Also following design codes, work instructions and checklists. - Communicate progress and deliverable updates to the stakeholders, raise red flags and highlight any concerns to all stakeholders. - Understanding priorities, job planning, training designers to execute the jobs with high quality within specified timelines defined by customers. - Maximize satisfaction level of customers in terms of quality of work, meeting deadlines and quick turnaround time. - Ensure proper co-ordination with other competences involved CAE, Electrical design etc. - Maintain high quality level by organizing reviews of own work and participating in reviews from other designers. - To resolve any engineering related issues during assembly, Testing and Inspections. - Produce presentation and documentation as needed for engineering and customer reviews of design work People Focus - Adhere to the Team spirit towards Driving Customer Success & Improving Business Results. - Inspire CAN DO; WILL DO attitude in yourself. - Take complete responsibility of executing assigned tasks. - Maintain a positive team moral with an open atmosphere of teamwork and co-operation - Co-ordination with internal & external clients for reporting status of task, resolving queries and receiving feedback. - Respect & contribute actively to the SHE procedures (Safety, Health, Environment) - It will be a challenge for you to further develop & expand the scope of activities and control the work done by external design agencies, onsite as well as off-site. Utilize efficiently the available contract Engineers. Technology Focus - Look for the innovative techniques other than standard practices been followed. - Generate innovative ideas through self-study of new technologies in market. - Nurture innovative ideas and focus improvements on the product performance, cost, life, reliability, Sustainability. - Promote sharing best practices across all product management teams. - Promote use of advance manufacturing techniques while designing new products. - Identify and implement AI-driven solutions to enhance design processes and improve overall efficiency Product Focus - Suggest different CAD automation projects to automate repeated processes & to improve the quality. - Follow Atlas Copco design codes, standards, work instructions & check lists of the tasks handled and carry out the checking. Ensure adherence to Quality Norms as set by the Project leader from time to time. - Continually innovate the ideas to improve the Quality aspect of engineering. - Create & Promote use of reusable components, product platforms, Subassemblies, Modular Designs. Promote ideas for continuous improvement & innovation To succeed, you will need Knowledge/Educational Requirements - The right candidate has a bachelor s degree Mechanical with minimum 3-5 years Industrial design experience. - Should have basic knowledge of Air Compressors and designing of compressor Packages. - Good knowledge in assembly technics and integration - Knowledge of Sheet metal, Piping design, Flange selection, heavy fabrication. Produce and check the 3D assembly and 2D drawings. - Should be familiar with design and implementation of Oil hydraulic, pneumatic systems and their controls used in compressor package. - Experience of working on CAD software like Autodesk Inventor, AutoCAD, ERP (BPCS/SAP) & PLM (Enovia) system. In return, we offer you A work culture known for respectful interaction, ethical behaviour and integrity. - Access to Global Job Opportunities as a part of Atlas Copco Group. - Opportunities to grow and develop. - Potential to see your ideas realized and to make an impact. - New challenges and new learnings. City Pune Last Day to Apply 17/06/2025

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0.0 - 2.0 years

3 - 4 Lacs

Mumbai

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Planit are world leaders in application testing and quality engineering. We provide solutions that support organisations to deliver high quality systems, applications, and IT architecture. Planit is now a proud NRI company and part of a global movement to deliver a sustainable and secure future through better Information Technology exchanges. Our team offer expert consultancy, bespoke services, tailored training and unique solutions to complex projects. Specialising in digital quality, Planit have a geographic footprint across many continents, with 1700+ permanent employees and have been recognised in Gartners Magic Quadrant for Application Testing Services. Our values and ethos are focused on an intrinsic connection to our people, the awareness of our environment and our pursuit to be better than yesterday. We continue to lead the industry with unrivalled ideas, ability, and a quest to discern paradigms About the role: The role demands here that the candidate should have working experience into Functional testing (i.e. to create the test cases, test scenarios, detect bugs). Along with this, stakeholder management, client interaction, and leadership qualities are an added advantage. Responsibilities : 0- 2 years of experience. Bachelors degree in computer science or equivalent field. Excellent Communication skills. Excellent Analytical & problem-solving skills.. knowledge of Software Testing . Knowledge of any programming Language (Java/ Python). Skills & Experience: 0 - 2 years of experience in Manual Testing Culture and Benefits: For the right person we will provide:- A competitive remuneration package with career pathways within our talent team as we continue to expand globally An open, flexible hybrid working environment where you can immediately see the impact of your work and delivery towards the business success All of the tools, software and support you need (we ve just undergone a migration of our ATS platform with bleeding edge tool /process to enable success) Benefits including health insurance, Free LinkedIn Learning licences, Training platforms & internet reimbursement among others. If you believe that this role is for you APPLY TODAY! www.planit.com Planit is an equal opportunity employer.

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10.0 - 15.0 years

10 - 14 Lacs

Bengaluru

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Job Summary What you need to know about the role As part of the Merchant Reporting & Insights team at PayPal, you will lead the development of mission-critical systems that ingest, orchestrate, and analyze massive volumes of data. These systems generate millions of high-volume reports, transforming complex fintech data into actionable business insights. You ll be responsible for ensuring timely delivery of reports aligned with merchant SLAs and business cadences. Meet our team The Merchant Reporting & Insights team is at the heart of PayPal s data-driven decision-making. We build scalable data platforms and reporting tools that empower merchants with real-time insights. You ll collaborate with cross-functional teams across engineering, product , customers to deliver impactful solutions that drive business outcomes. Your way to impact You will lead the design and development of scalable, enterprise-grade data solutions that power critical reporting for merchants globally. Your leadership will drive innovation in big data and real-time processing, ensuring high-throughput systems meet business needs. You ll foster a culture of technical excellence, collaboration, and continuous improvement. Job Description Your Day-to-Day Provide technical leadership and guidance to teams of software engineers, fostering a culture of collaboration, innovation, and continuous improvement. Establish outcomes and key results (OKRs) and successfully deliver them. Drive improvements in key performance indicators (KPIs). Increase the productivity and velocity of delivery teams. Develop, plan, and execute engineering roadmaps that bring value and quality to our customers. Collaborate and coordinate across teams and functions to ensure technical, product, and business objectives are met. Instill end-to-end ownership of products, projects, features, modules, and services that you and your team deliver in all phases of the software development lifecycle. What do you need to bring 10+ years of experience in the software industry, with 3+ years of professional experience leading software development teams. Strong critical thinking and problem-solving skills with the ability to address complex technical and non-technical challenges. Experience building and developing engineering teams that exhibit strong ownership, user empathy, and engineering excellence. Proven track record of delivering high-quality systems and software in Big Data Technologies including Spark, Airflow, Hive, etc., with practical exposure to integrating machine learning workflows into data pipelines. Proven track record of delivering high-quality systems and software in Java/J2EE technologies and distributed systems, with experience deploying ML models into production at scale using REST APIs, streaming platforms, or batch inference. Excellent communication skills with the ability to collaborate effectively with cross-functional teams (including data scientists and ML engineers) and manage stakeholders expectations. Ability to coach and mentor talent to reach their full potential, including guiding teams in adopting MLOps best practices and understanding AI model lifecycle management. Experience in building large scale, high throughput, low latency systems, including real-time data processing systems that support personalization, anomaly detection, or predictive analytics. Strong understanding of software development methodologies, modern technology topics and frameworks, and developer operations best practices. Experience with ML platforms (e.g., Kubeflow, MLflow) and familiarity with model monitoring, feature engineering, and data versioning tools is a plus. Provide leadership to others, particularly junior engineers who work on the same team or related product features. Proven experience delivering complex software projects and solutions effectively through Agile methodologies on a regular release cadence. Strong verbal and written communication skills. Strong customer focus, ownership, urgency and drive.

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3.0 - 5.0 years

8 - 12 Lacs

Pune

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Your primary role is to be a vital member of the team and a main point of contact for customer projects. Your mission is to contribute to product management activities from an engineering perspective, while also enhancing the technical proficiency of the GECIA team with a solution-oriented mindset. To accomplish this, you will need to continually improve your own skillset and familiarize yourself with the latest technology platforms. Additionally, you will be responsible for ensuring on-time delivery and a first-time right approach in all your work. Key Responsibilities - Study & Analyse Technical Specifications for Scope, Technical requirements and work content based on the inputs received. - Generate 3D layouts, detail engineering and drawings for new deigns, Customised/ES Piston products and Skid Packages. - Monitor performance parameter like Timely completion, Quality of drawings and First time right. - Generating necessary documents for task as per SOP s and Quality Systems. Also following design codes, work instructions and checklists. - Communicate progress and deliverable updates to the stakeholders, raise red flags and highlight any concerns to all stakeholders. - Understanding priorities, job planning, training designers to execute the jobs with high quality within specified timelines defined by customers. - Maximize satisfaction level of customers in terms of quality of work, meeting deadlines and quick turnaround time. - Ensure proper co-ordination with other competences involved CAE, Electrical design etc. - Maintain high quality level by organizing reviews of own work and participating in reviews from other designers. - To resolve any engineering related issues during assembly, Testing and Inspections. - Produce presentation and documentation as needed for engineering and customer reviews of design work - Adhere to the Team spirit towards Driving Customer Success & Improving Business Results. - Inspire CAN DO; WILL DO attitude in yourself. - Take complete responsibility of executing assigned tasks. - Maintain a positive team moral with an open atmosphere of teamwork and co-operation - Co-ordination with internal & external clients for reporting status of task, resolving queries and receiving feedback. - Respect & contribute actively to the SHE procedures (Safety, Health, Environment) - It will be a challenge for you to further develop & expand the scope of activities and control the work done by external design agencies, onsite as well as off-site. Utilize efficiently the available contract Engineers. - Look for the innovative techniques other than standard practices been followed. - Generate innovative ideas through self-study of new technologies in market. - Nurture innovative ideas and focus improvements on the product performance, cost, life, reliability, Sustainability. - Promote sharing best practices across all product management teams. - Promote use of advance manufacturing techniques while designing new products. - Identify and implement AI-driven solutions to enhance design processes and improve overall efficiency - Suggest different CAD automation projects to automate repeated processes & to improve the quality. - Follow Atlas Copco design codes, standards, work instructions & check lists of the tasks handled and carry out the checking. Ensure adherence to Quality Norms as set by the Project leader from time to time. - Continually innovate the ideas to improve the Quality aspect of engineering. - Create & Promote use of reusable components, product platforms, Subassemblies, Modular Designs. Promote ideas for continuous improvement & innovation To succeed, you will need Knowledge/Educational Requirements - The right candidate has a bachelor s degree Mechanical with minimum 3-5 years Industrial design experience. - Should have basic knowledge of Air Compressors and designing of compressor Packages. - Good knowledge in assembly technics and integration - Knowledge of Sheet metal, Piping design, Flange selection, heavy fabrication. Produce and check the 3D assembly and 2D drawings. - Should be familiar with design and implementation of Oil hydraulic, pneumatic systems and their controls used in compressor package. - Experience of working on CAD software like Autodesk Inventor, AutoCAD, ERP (BPCS/SAP) & PLM (Enovia) system. In return, we offer you A work culture known for respectful interaction, ethical behaviour and integrity. - Access to Global Job Opportunities as a part of Atlas Copco Group. - Opportunities to grow and develop. - Potential to see your ideas realized and to make an impact. - New challenges and new learnings.

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8.0 - 10.0 years

7 - 11 Lacs

Bawal, Chennai, Gurugram

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Create a better future! Do you want to make a difference in the world and contribute to a sustainable future? We believe we can develop technology and gain the knowledge to make that difference. We have launched our ambition, Mission Zero - enabling our customers to move towards zero emissions in mining We need your leadership skills, curiosity, and drive for change to fulfil our goal. Together, we enable our customers to produce the materials needed for a better future. Job Summary: The QA Specialist will be responsible for driving quality performance and compliance across all FLSmidth manufacturing units in the APAC and EMEA regions. This role will implement global quality processes, lead non-conformance management, leverage data for insights, and ensure audit readiness across regional sites. It will also support continuous improvement and alignment with business and regulatory standards. Key Responsibilities: Develop and maintain the regional Quality Management System (QMS), ensuring site-level documentation is compliant with ISO 9001 and aligned with global standards. Plan and conduct internal IMS audits at manufacturing sites in partnership with local HSE teams, identifying non-conformities and ensuring timely corrective actions. Lead the Non-Conformance (NC) Management process via Intelex across APAC & EMEA manufacturing operations, ensuring issue tracking, root cause analysis, and horizontal deployment of preventive actions. Monitor key quality performance indicators (KPIs), including NC closures, COPQ, defect trends, and process capability, while working with site teams to meet improvement goals. Analyse quality data from Intelex and other systems to identify trends, generate actionable insights, and drive continuous improvement initiatives across sites. Support and drive site-level continuous improvement using Lean, Six Sigma, and Value Stream Mapping (VSM) to boost process and product quality. Prepare for and support external ISO audits and customer audits, ensuring readiness and certification compliance across manufacturing sites. Train and support plant teams on Intelex Tool usage, audit preparedness, quality tools, and structured problem-solving methods. Facilitate cross-site collaboration through regular quality review meetings, knowledge-sharing forums, and best practice sessions across APAC & EMEA regions. Collaborate with Operations, Engineering, and Supply Chain functions to integrate robust quality control mechanisms within manufacturing processes. Promote and uphold a strong safety culture through integration of safety practices within quality systems and daily operations What you bring Bachelor s degree in Mechanical, Industrial, or Production Engineering (or equivalent technical discipline). 8 to 10 years of progressive experience in Quality Assurance within a manufacturing environment, preferably in global or multi-site roles. Strong working knowledge of ISO 9001, audit processes, and QMS systems. Hands-on experience with Intelex or similar digital quality platforms. Strong analytical skills with working knowledge of Power BI and/or Minitab for data visualization, statistical analysis, and quality performance reporting. Proficient in quality tools such as 8D, RCA, Fishbone, APQP, FMEA, and 5 Whys. Practical exposure to Lean, Six Sigma, and continuous improvement methodologies (Green Belt or higher preferred). Strong written and verbal communication skills in English/Hindi. Ability to work across cultures and time zones with cross-functional, global teams What we offer Competitive benefit package including Health Insurance, Personal Accident / Disability, Group Term Life Insurance, Annual health check-up, and voluntary insurance options. Time to recharge through 30 days PTO (with up to 10 days carry forward as Earned Leave stock) Work-life balance with a flexible work schedule so you can focus on professional and personal priorities. Financial support for continuing education Employee Assistance Program A global network of supportive colleagues and growth opportunities We encourage applicants of all backgrounds and perspectives to apply - the more diverse our employees are, the stronger our team is. FLSmidth is a full flowsheet technology and service supplier to the global mining and cement industries. We help our customers to improve performance, lower operating costs and reduce environmental impact. - for more information please visit .

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3.0 - 8.0 years

4 Lacs

Bengaluru

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Job Title: QC Analyst I At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site lead, the Quality Control Analyst is responsible for managing the day today activities quality control function at Cepheid India Private Ltd. Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements. In this role, you will have the opportunity to: Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs). Competent technical staff for supervision the Testing/ analysis of diagnostic reagents & kits. Perform inspections of incoming, in-process and finished products. Performs and calibration and maintenance of lab equipment as per requirements. May perform special projects on analytical and instrument problem solving. Ensure that lab cleanliness and safety standards are maintained. Qualify test methods as part of new product development activities. Serve as a technical liaison between quality control and other departments Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses & Write or revise standard quality control operating procedures. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines. Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Review records and documents for completeness and compliance with company policies and procedures. Support for internal audit schedule, NC, CAPA for site. Review production batch records, QC test results and release product. Education and Experience: Master s degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years experience with in Vitro Diagnostics (IVD) is mandate Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable Quality competent technical person approved as per D&C act if any Knowledge and skills: Hands on Experience on IVD product testing. Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS. Must be flexible to work off-shifts and weekends as per production Schedule. Schedule orientated (able to consistently maintains schedules and meet timelines) Strong interpersonal skills, Effective organization and Communication skills are essential. Good skills in English language Knowledge of Microsoft Word and Excel Strong multi-tasking and attention to details skills. It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Able to interpret quality problem and establish practical solutions within a dynamic business environment. Experience in leading continuous improvement efforts, in both quality systems and products. Knowledge of the process of establishing facility QMS certifications. Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable. When you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here . We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. . Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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1.0 - 3.0 years

3 - 5 Lacs

Pune

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Key Responsibilities: Provides administrative and logistics support for a project team and project manager, executing clearly defined tasks in administration and logistics. Serves as a support resource on projects and work assignments as clearly defined by Project Coordinator or Manager, utilizing basic knowledge of effective project management with general business understanding. Assists in identifying, tracking, and working with others to resolve project issues. Helps to monitor and communicate project status to project team using data visualization and communication tools under guidance of Project Coordinator or Manager. Assists with budget tracking, project research tasks, and provides administrative support for the design and development of project plans and timelines. Assists with identifying project risk, using Quality tools and methods to track risks under the guidance of Project Manager. Documents and shares team lessons learned and best practices with other teams under the guidance of Project Manager. Maintains project notes, databases and other records and communicates with Project Manager on status of projects, assignments and individual tasks. Skills Required:- Experience in in Quality / Quality Systems Required. Should be able to support wide range of activities ranging from NC handling to product documentation reviews to Change management administration to ad-hoc special project support, as and when required by the organization. Should have adequate business communication skills to convey & comprehend technical requirements while in conversations with Global Stakeholders. Competencies Communicates effectively - Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences. Customer focus - Building strong customer relationships and delivering customer-centric solutions. Manages complexity - Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. Plans and aligns - Planning and prioritizing work to meet commitments aligned with organizational goals. Resourcefulness - Securing and deploying resources effectively and efficiently. Project Issue and Risk Management - Manages the process to identify, assess and prioritize issues and risks using recommended tools and disciplines. Drives actions to minimize, monitor and control risks and issues and to maximize the most positive outcomes possible. Project Resource Management - Develops resource (expense and headcount) plans using recommended project management tools and processes to manage resources effectively. Project Schedule Management - Manages the planned schedule using the recommended schedule management tools and processes to drive completion within the agreed timeline. Project Scope Management - Manages a list of project deliverables (scope) using the recommended project management tools and processes to ensure that the project includes all the work required and only the work required to complete the project successfully. Values differences - Recognizing the value that different perspectives and cultures bring to an organization. Continuous Improvement Leadership - Proactively and responsively applies system, process and customer centric perspective with structured quality disciplines, tools and methodologies to problem solving and continuous improvement throughout the enterprise, leading efforts to define issues, risks or failures and to create and implement sustainable solutions or improvements. Education, Licenses, Certifications High school diploma or certificate of completion of secondary education or equivalent experience to the extent such experience meets applicable regulations. College or equivalent degree preferred. This position may require licensing for compliance with export controls or sanctions regulations. Experience Requires work experience and intermediate level knowledge obtained through training or on the job experience. Administrative /support experience preferred.

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0.0 - 2.0 years

3 - 4 Lacs

Mumbai

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Planit are world leaders in application testing and quality engineering. We provide solutions that support organisations to deliver high quality systems, applications, and IT architecture. Planit is now a proud NRI company and part of a global movement to deliver a sustainable and secure future through better Information Technology exchanges. Our team offer expert consultancy, bespoke services, tailored training and unique solutions to complex projects. Specialising in digital quality, Planit have a geographic footprint across many continents, with 1700+ permanent employees and have been recognised in Gartners Magic Quadrant for Application Testing Services. About the role: The role demands here that the candidate should have working experience into Functional testing (i. e. to create the test cases, test scenarios, detect bugs). Along with this, stakeholder management, client interaction, and leadership qualities are an added advantage. Responsibilities : 0- 2 years of experience. Bachelors degree in computer science or equivalent field. Excellent Communication skills. Excellent Analytical problem-solving skills. . knowledge of Software Testing . Knowledge of any programming Language (Java/ Python). Skills Experience: 0 - 2 years of experience in Manual Testing Culture and Benefits: For the right person we will provide:- A competitive remuneration package with career pathways within our talent team as we continue to expand globally An open, flexible hybrid working environment where you can immediately see the impact of your work and delivery towards the business success All of the tools, software and support you need (we ve just undergone a migration of our ATS platform with bleeding edge tool /process to enable success) Benefits including health insurance, Free LinkedIn Learning licences, Training platforms internet reimbursement among others. If you believe that this role is for you APPLY TODAY! www. planit. com Planit is an equal opportunity employer.

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2.0 - 7.0 years

19 - 20 Lacs

Pune

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Process Issues/Quality issues Resolution related to gear manufacturing. Awareness and knowledge of latest technology changes, cutting tool materials and geometries. Conduct straining on tools and tooling on latest trends. Identification of Tool life improvement projects or replacement of tool with alternate technology. Defect identification and root cause analysis. New model Machining set up , line setup and ramp up. Capacity improvements through debottlenecking and improvements. Rejection system-implementation of zero rejection concept. Revenue cost reductioninitiatives for implementation and practice Improvement idea generation and implementation. Interaction with all support functions and concern resolution with the help of CFT. Generate Safe working culture. Develop improvement culture. Knowledge of quality systems and adherence through review. Implementation of TPM in Machining. Driving tool cost reduction, Power cost Reduction and productivity improvement projects. Benchmark best practices across other plants and industry for manufacturing excellence. Knowledgeable of QS 9000 , DCP, PFMEA, Control Plan. Drive Productivity through regular reviews for indicators like OLE, OEE Preferred Industries Automobile Education Qualification Bachelor of Engineering in Automobile; Bachelor of Engineering in Production; Bachelors of Technology; Bachelor of Engineering General Experience 2-7 years Critical Experience System Generated Core Skills Analytical Thinking Change Management Communication Skills Conflict Management Failure Mode and Effects Analysis (FMEA) Measurement System Analysis (MSA) MOST Technique Statistical Process Control (SPC) Team Management Quality Control System Generated Secondary Skills

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3.0 - 6.0 years

2 - 5 Lacs

Bengaluru

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Job Description Job Summary Manage and lead technical inspection services and activities related to global equipment industrial, modifications and repairs in accordance with project and/or production contractual requirements. Manage and add resource if needed and continuously improve the capability (through training needs analysis and hiring of people with the right skills and knowledge) and structure of the Product Quality Assurance team to meet business objectives. Measuring, monitoring and report quality control standards relating to project and production. Ensure project and production standards comply with relevant classification rules in accordance with specifications and scopes of works. Responsible in the development, management and maintenance of Avernas quality management systems including Business Management System, company standards, and ISO 9001 :2015 certifications. Provide system auditing functions and oversee relevant document control systems. Responsibility for final manufacture data record of project. Roles and Responsibilities Manage, assign works for Product Quality Assurance staffs to complete well and ensure manufacturing quality. Based on Incoming Quality Inspection test results, decide to repay goods to suppliers or transfer to MRB. Be responsible for plans to ensure quality: basing on drawings, DFM, information from customers. Review and check drawings & approve drawings for manufacture and installation. Read and understand client specifications and class rules for each project requirement. Review materials certification to comply with approved drawings and contract specifications. Compile testing summary reports for production analysis. Manage materials incoming inspection and compare with Purchase Orders and material mill certificates. Undertake visual inspection of incoming materials for each project. Control projects fit up inspections according to inspection and test plan. Undertake dimension inspection and compile reports for record keeping. Support in review the business management system procedures and ISO system procedures, Quality Objectives. Implement new departmental systems in conjunction with the Quality Head and train staff in effective use. Work with other departments to ensure overall performance is consistent Provide consultancy and expertise across the various departments relating to quality control and quality management. Prepare and generate suitable reports to ensure adequate information is supplied to internal and external stakeholders regarding quality. Follow approved company processes as defined in Business Management System Look for on-the-job opportunities to broaden and improve work knowledge base Achievement against the agreed goals/targets Maintain quality of works and the completion of work plan against the committed deadline Minimize ratio of complaints or grievances related to allocated responsibilities Keep up-to-date and seek to implement industry best practices. Qualifications Bachelors degree in Engineering (Mechanical / Mechatronics / Electrical) with minimum 3 years of experience in a similar position within a large manufacturing organization or high-tech industry Quality auditor qualifications (ISO standards preferred) Knowledge of lean manufacturing and quality systems implementation.

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0.0 - 1.0 years

0 Lacs

Noida

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" JOB DESCRIPTION Jubilant Bhartia Group Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees. About Jubilant Biosys Jubilant Biosys Ltd is a part of the Jubilant Pharmova family of companies with R&D centres in India and business offices in Asia and North America. With our global reach, Jubilant Biosys provides comprehensive drug discovery services and contract research services from target discovery to candidate selection and with flexible business models (FFS, FTE and risk shared) in partnership with leading worldwide healthcare companies. With a clear scientific focus in oncology, metabolic disorders, central nervous system (CNS) diseases, pain and inflammation, Jubilant Biosys has rapidly emerged as a leading collaborator for pharmaceutical and biotechnology companies worldwide. In each of these therapeutic areas, Jubilant Biosys has developed a deep level of expertise in discovery informatics, computational chemistry , medicinal chemistry, structural biology , biology, in-vivo , in-vitro models and translational sciences. Combined with strong clinical development and manufacturing capabilities from other Jubilant subsidiaries, Jubilant Biosys has risen as a fully integrated contract research organization in India and headquartered at Bengaluru with end-to-end solutions. Our ability to be the preferred collaborator in the drug discovery domain is sustained by our commitment to comply with and continually improve our quality systems and to provide the following services: Contract Research Preclinical CRO Drug Discovery Virtual Screening Protein Crystallization Toxicology & In-vitro ADME Medicinal Chemistry Synthetic & Developmental Chemistry Pharmacology Jubilant Biosys collaborates with the world s leading pharmaceutical, biotech companies, academic institutions and research foundations. Find out more about us at www.jubilantbiosys.com The Position Organization : - Jubilant Biosys Designation & Level: - Trainee research Associate/ A0 Location : - Greater Noida Department: - Synthesis Reporting Manager: - Group Leader Key Responsibilities Synthesis, purification and characterization of chemical intermediates. Deliver small to large quantities of novel chemical entities for drug discovery. Work collaboratively in a team to drive chemistry projects forward. Excellent knowledge of basic organic chemistry with mechanism. Good knowledge of Name Reactions & functional group transformation. Good knowledge of molarity, normality, equivalency. Practical experience in thin-layer chromatography, column purification and extraction. Good understanding of NMR, IR and mass spectrometry. Interest to adapt and knowledge of laboratory safety practices. Enthusiasm to work in a dynamic research environment. Good Soft & Scientific Communication skills. Person Profile Qualification: - M.Sc. in Chemistry/Organic Chemistry/Pharmaceutical Chemistry or related field or M. Pharma (Specialized in Organic Synthesis) with 0-1 years project experience. Experience: - 0-1 year of exp. Jubilant is an equal opportunity employer. . ",

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5.0 - 10.0 years

7 - 12 Lacs

Hyderabad

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Job title : Global stability management manager Grade: Level 2.2 Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Provide strategic direction to the global stability management team, aligning activities with company goals and regulatory requirements Oversee daily operations of stability management activities, ensuring timely and accurate completion of tasks and overall performance Drive continuous improvement initiatives within the stability management processes and methodologies Mentor, coach, and develop team members, conducting performance evaluations and facilitating professional growth Act as the liaison between the stability management team and the global hub leadership team, ensuring alignment and effective communication Align with global quality team and ensure that all documentation standards are applied Oversee the preparation, review, and approval of stability management reports, ensuring accuracy and completeness Deliver high-quality service to internal customers (sites), addressing their needs and expectations Maintain collaborative relationships with key stakeholders to ensure smooth execution of qualification activities About you Experience : >5 years professional experience in qualification and proven leadership track record Soft skills : Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments Technical skills : Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point Education : Master or Bachelor degree in Engineering, Pharmacy, Chemistry, or a related field. Advanced degree (e.g., PhD) preferred Languages : Excellent English communication and writing, French or other Languages in addition preferred Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

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4.0 - 6.0 years

6 - 8 Lacs

Vadodara

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Job Title: Senior Specialist, Microbiology Location: Vadodara Job Model: Office Role Purpose of the position: Purpose of this position to maintain and continually improve the quality of products, processes & quality systems to provide right quality and services to the customers. Supports the implementation and execution of the quality, food safety, cleaning, and sanitation management systems within DSM-F HNC Premix Ensure the smooth operation of the Microbiology instruments for daily sample analysis Responsible for the calibration and preventive maintenance of the microbiology instrument and equipment as well as coordinating with the supplier/vendor of the equipment in case of breakdown and Preventive maintenance. Maintains the master equipment list and ensures that the performance verification methodologies conform to some recognized standards and the equipment is operating under validated specifications. Ensure that the units are operating according to specifications, Ensure that appropriate inventory of consumables are maintained for lab operations. Responsible for test method development and transfer, qualification of test methods and new laboratory instruments according to Pharmacopeia/In house/ ISO methods and Customer requirement any failure investigation of test method/procedure of Instrument. Assists the QA/QC Manager in maintaining the QMS microbiology and FSSC 22000 system implemented in the plant. This includes reviewing and improving on the existing process, procedures and instructions. Ensure that lab operations are carried out as per good laboratory practice (GLP). Key responsibilities: Ensure the smooth running of the Microbiology laboratory RM, PM and FG analysis are done as per their specification. Culture Maintenance. Environmental Monitoring. In-charge of the calibration and Preventive Maintenance of instruments and equipment to ensure good quality of Microbiology results. Preparation and updating SOP regarding microbiology standard methods. Source and recommend new test instrument when required and carry out qualification (IQ, OQ & PQ) of the instrument with the vendor so as to put it to use for routine testing in shortest time possible. Maintain technical data, generate reports and findings. Write relevant instrumental or procedural SOPs for the work operations. Assist the QA Manager to review and improve Microbiology procedures and instructions related to the ISO QMS and FSSC 22000 standards/LOP/SOP. Calibration and validation of Microbiology equipment. Risk assessment Microbiology Ensure that plant EMP programme is thoroughly implemented. Ensure Plant Environmental contamination incidents are investigated thoroughly and support to improve overall hygiene standards. Ensure that DSM cleaning and sanitation standards are adhered across the site. Support region for Hygiene related investigations and serve as a key resource. Conduct shop floor Gemba walks and suggest areas for improvement for hygiene/ sanitation. Actively involve in cleaning validations and verifications. Look for opportunities of cost savings in sanitation practices. Responsible for actively participating in Change management (MOC) risk assessment related to Hygiene/ sanitation. Conduct regular trainings to shop floor team on cleaning and sanitation standards. Escalate Food safety risk indicators if any from time to time to the senior management and prevent food safety risks. Keep himself/herself abreast of latest hygiene/sanitation standards and implement best in class standards. Conducts staff training of site cleaning and sanitization procedures. Oversees & monitors housekeeping and cleaning programs. Performs daily audits of manufacturing and production to identify micro risk areas, clean design defects, and proper adherence and execution of C&S procedures. Oversees teardown and re-assembly process from a hygienic perspective. Participates in company continuous improvement initiatives by seeking out improved ways to clean and sanitize more efficiently & effectively. Coordinates with other operational units to maintain compliance and perform. Communicates with all sites in the region and globally to ensure consistency and sharing of best practices.

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8.0 - 12.0 years

9 - 13 Lacs

Gurugram

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Sr. Core Business Support Engineer II Job Details | Hollister Incorporated Search by Keyword Search by Location (City, State, Country) Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Sr. Core Business Support Engineer II May 29, 2025 Gurugram, HR, IN, 122002 Hollister Global Business Services India Private L work mode: hybrid work location: gurgaon SUMMARY The Sr.Core Business Support Engineer II will lead and contribute to product and process change projects for existing Hollister products and processes in both our Ostomy Care and Critical Care businesses. The projects will be primarily related to Technical Transfer, Process Change, Material Change, Supply Security (stay in business), and Cost Savings. This is a permanent position based at the Gurugram facility. Live the Hollister Immutable principles, Develop test plans, analyze test data and interpret result Generate original ideas based on professional knowledge of product design for both ostomy and critical care products. Develop realistic action steps, timetables, and resource estimates for technical projects. Identifies potential challenges and proactively work to address them. Actively participate on cross-functional teams (international) and supports the completion of team deliverables. Validate plans within the team and acts on suggestions for improvement. Establishes a rapport with their working teams which allows them to identify key resources and network efficiently. Supports technical management in establishing goals and strategies. Communicate effectively and review project outcomes with internal customers. Completes written reports on technical activities carried out. Prepares and updates a range of technical documents including drawings and specifications. Provides technical support to Manufacturing, Engineering, Quality and Supply Chain. ESSENTIAL FUNCTIONS OF THE ROLE General office environment - position may require sitting at a desk / computer for extended periods of time . The position also will require travel to other Hollister facilities and various suppliers ( 10%). Talking, walking, vision, hearing, fine motor skills, writing, lifting up to 30 lbs.(occasionally), and pushing Some, but not all aspects of this job could be modified to accommodate the physical abilities of a handicapped person WORK EXPERIENCE REQUIREMENTS 8 to 12 years experience in a similar position, preferably in the medical devices sector Proven track record in project management and project leadership; capable of working independently Uses problem solving techniques such as DMAIC to resolve issues as they arise Demonstrates working knowledge of standard techniques, procedures, and criteria in accomplishing well-defined tasks Strong communication skills, with ability to articulate relevant technologies and processes to others in the technical group and provide project updates to non-technical key stakeholders Solves technical issues using alternative or unique approaches Recognizes value-added product features and integrates them into product designs Demonstrates awareness of current technological trends, especially within their specific discipline Previous knowledge or experience in field of Ostomy, Continence care would be added advantage (not mandatory) Previous knowledge or experience in polymer films, bonding technology would be added advantage (not mandatory) Ability to create, read, edit, and interpret 2D and 3D drawings as well as product specifications (with minimal oversight). EDUCATIONAL REQUIREMENTS Bachelor of Science / Engineering degree or higher preferably with Mathematics or Statistics as a subject PMP Certification is desirable (not essential) SPECILIZED SKILLS/ TECHNICAL KNOWLEDGE Experience with the FDA Quality Systems Regulations and an ISO 13485 environment at a medical device manufacturer (preferred) Project management training and experience (preferred) Experience with product development, design controls, change controls and risk management for medical devices. Advanced statistics training and experience with plastic proicessing and/or automated assembly processes (nice to have) LOCAL SPECIFICATIONS (Work Environment / Language) Hybrid work environment with 3 days in the office and 2 days at home performance based Two days per week will require flexible work hours to accommodate international project work with the USA and Europe R&D, Facilities, Project Manager, Risk Management, Supply Chain, Research, Operations, Technology, Finance

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7.0 - 9.0 years

10 - 12 Lacs

Vadodara

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Job Title: Senior Specialist, Microbiology Location: Vadodara Job Model: Office Role Purpose of the position: Purpose of this position to maintain and continually improve the quality of products, processes & quality systems to provide right quality and services to the customers. Supports the implementation and execution of the quality, food safety, cleaning, and sanitation management systems within DSM-F HNC Premix Ensure the smooth operation of the Microbiology instruments for daily sample analysis Responsible for the calibration and preventive maintenance of the microbiology instrument and equipment as well as coordinating with the supplier/vendor of the equipment in case of breakdown and Preventive maintenance. Maintains the master equipment list and ensures that the performance verification methodologies conform to some recognized standards and the equipment is operating under validated specifications. Ensure that the units are operating according to specifications, Ensure that appropriate inventory of consumables are maintained for lab operations. Responsible for test method development and transfer, qualification of test methods and new laboratory instruments according to Pharmacopeia/In house/ ISO methods and Customer requirement any failure investigation of test method/procedure of Instrument. Assists the QA/QC Manager in maintaining the QMS microbiology and FSSC 22000 system implemented in the plant. This includes reviewing and improving on the existing process, procedures and instructions. Ensure that lab operations are carried out as per good laboratory practice (GLP). Key responsibilities: Ensure the smooth running of the Microbiology laboratory RM, PM and FG analysis are done as per their specification. Culture Maintenance. Environmental Monitoring. In-charge of the calibration and Preventive Maintenance of instruments and equipment to ensure good quality of Microbiology results. Preparation and updating SOP regarding microbiology standard methods. Source and recommend new test instrument when required and carry out qualification (IQ, OQ & PQ) of the instrument with the vendor so as to put it to use for routine testing in shortest time possible. Maintain technical data, generate reports and findings. Write relevant instrumental or procedural SOPs for the work operations. Assist the QA Manager to review and improve Microbiology procedures and instructions related to the ISO QMS and FSSC 22000 standards/LOP/SOP. Calibration and validation of Microbiology equipment. Risk assessment Microbiology Ensure that plant EMP programme is thoroughly implemented. Ensure Plant Environmental contamination incidents are investigated thoroughly and support to improve overall hygiene standards. Ensure that DSM cleaning and sanitation standards are adhered across the site. Support region for Hygiene related investigations and serve as a key resource. Conduct shop floor Gemba walks and suggest areas for improvement for hygiene/ sanitation. Actively involve in cleaning validations and verifications. Look for opportunities of cost savings in sanitation practices. Responsible for actively participating in Change management (MOC) risk assessment related to Hygiene/ sanitation. Conduct regular trainings to shop floor team on cleaning and sanitation standards. Escalate Food safety risk indicators if any from time to time to the senior management and prevent food safety risks. Keep himself/herself abreast of latest hygiene/sanitation standards and implement best in class standards. Conducts staff training of site cleaning and sanitization procedures. Oversees & monitors housekeeping and cleaning programs. Performs daily audits of manufacturing and production to identify micro risk areas, clean design defects, and proper adherence and execution of C&S procedures. Oversees teardown and re-assembly process from a hygienic perspective. Participates in company continuous improvement initiatives by seeking out improved ways to clean and sanitize more efficiently & effectively. Coordinates with other operational units to maintain compliance and perform. Communicates with all sites in the region and globally to ensure consistency and sharing of best practices.

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3.0 - 6.0 years

6 - 8 Lacs

Bengaluru

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Responsibilities: * Conduct quality audits & ISO Standards,document findings * Ensure compliance with industry standards * Implement quality systems & processes * Oversee final inspections & manage quality control Health insurance Provident fund Office cab/shuttle

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2.0 - 7.0 years

2 - 5 Lacs

Pune

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Urgent Required Sr. Quality Engineer in manufacturing company for Chimbali, Pune location. Required Qualification: Diploma / BE Preferred candidate from Automotive industry. Required Experience - 2 Yrs. - 4 years Role & responsibilities 1. Handling Incoming quality inspections team. 2. PDIR for each supply 3. Excellent communication skills and interpersonal skills. 4. Should be able to coordinate with end customer independently for any customer complaint / requirement. 5. Good in MIS preparation. 6. Knowledge of QMS, ISO, IATF and other quality standards. 7. Developing and implementing quality standards and quality control systems 8. Monitoring and analysing quality performance. 9. Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. 10. Collaborating with operations team to develop and implement controls and improvements. 11. Ensuring that workflows, processes, and products comply with safety regulations. 12. Investigating and troubleshooting product or production issues. 13. Developing corrective actions, solutions, and improvements. 14. Reviewing codes, specifications, and processes. 15. Strong analytical and problem-solving skills..

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2.0 - 7.0 years

3 - 5 Lacs

Bengaluru

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Job Title: Quality and Regulatory Manager (Medical Devices) Reports to: Director of Quality / Head of Operations Job Summary The Quality and Regulatory Manager is responsible for ensuring that all medical device products comply with global regulatory requirements (e.g., US FDA, EU MDR, ISO 13485), maintaining effective quality management systems, and facilitating successful regulatory submissions. The role involves leading internal and external audits, managing documentation, and supporting cross-functional teams to ensure the safety, efficacy, and compliance of medical devices throughout the product lifecycle. Key Responsibilities Quality Management System (QMS): Develop, implement, and maintain the QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations. Lead internal and external audits, and manage corrective and preventive action (CAPA) processes. Ensure proper documentation, control, and retention of quality records and regulatory files. Oversee product nonconformance investigations and ensure timely closure of deviations. Regulatory Affairs: Prepare, compile, and submit regulatory filings (510(k), CE Mark Technical Files, etc.) for new and existing products in global markets. Monitor and interpret global regulatory changes, ensuring the company remains in compliance. Serve as primary contact for regulatory agencies and notified bodies during inspections and audits. Develop and maintain product registration dossiers and technical documentation. Risk Management: Lead risk management activities in accordance with ISO 14971, including hazard analysis and post-market surveillance. Support product recalls, field safety corrective actions, and complaint investigations. Training & Continuous Improvement: Train and mentor staff on quality and regulatory requirements. Drive continuous improvement initiatives for product and process quality. Cross-Functional Support: Collaborate with R&D, Manufacturing, Supply Chain, and Marketing to ensure compliance in product design, labeling, packaging, and advertising. Support new product development teams with regulatory strategy and submission pathways. Qualifications & Requirements Bachelors or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field. Minimum 2 years’ experience in quality and/or regulatory roles in the medical device industry. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and related standards/regulations. Experience preparing regulatory submissions (510(k), PMA, CE Mark, etc.). Lead Auditor certification for ISO 13485 (preferred). Excellent written and verbal communication skills. Strong organizational and project management abilities. Key Competencies Detail-oriented and analytical. Problem-solving and decision-making skills. Ability to work cross-functionally and lead teams. Up-to-date with global regulatory trends and requirements. Location: [Insert location] Employment Type: [Full-time/Part-time/Contract] Let me know if you want to add anything about company culture, reporting structure, or specific product lines!

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6.0 - 8.0 years

5 - 8 Lacs

Greater Noida

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Quality manager, Manage overall QMS - qc, qa, sqa, line quality, RCA, Documents, audits, strong knowledge of either Powder Coating, Liquid Painting , Zinc Electroplating, CED, work exp of JBM, Delphi, Badwe, Panse preferred

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