289 Quality Systems Jobs - Page 8

JOB DESCRIPTION Designation: Executive Job Location : Bangalore Job Grade : 9 The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific: Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. Pre -execution activity: Area and equipment readiness. Issuance of raw material /consumables and issuance batch records. Upstream process execution: Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close monitoring of batch performance and data. Follow and practice on-line documentation all the time. Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC and EAM. Attend the training session of EHS, cGMP and HRD. Ensure process equipments/instruments are in Qualified in state. Verify PM, check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution. Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks. Perform on-line documentation, cGMP compliance in all the manufacturing activity, and timely closure of executed documents and batch records. Ensure the Quality system is followed in day today upstream operations. Identify the gaps in the system to improve. Active involvement in all upstream manufacturing activities. Perform error free operation by eliminating operational gaps in advance. Active trouble shooting to minimize the various risks prior to execution and during execution. Initiate and process upstream deviations /investigations and closure. TECHNICAL /FUNCTIONAL SKILL: Expertise in Upstream unit operations (CHO based mammalian expression systems). Strong Hands on experience with SUB (Up to 2000 L scale) Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area. Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects Experience on risk assessment tools and change management. Experience on the Equipment Qualification and commission aspects Education and Experience Education Master s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 0-4 years of relevant practical experience in Upstream Manufacturing for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc. Equal Opportunity Employer . Pls visit us at https://syngeneintl.com/ to know more about us and what we do.

RPG Group Position: Manager - Quality (M1 / M2) Job Family: Quality Summary: This position will be responsible for continuous improvement in Quality. Will be focal coordinator from corporate quality team and SBU quality teams. Will report to In-charge Corporate Quality Function. Location: Mumbai Pre-Requisite : Need to have at least 12 years experience in Quality & Cont. improvement preferably from big EPC company with required qualification or large multinational Engineering companies. Need to have good exposure to Microsoft Excel (Proficient), Share point and Power BI tools Key Responsibilities : Coordination with Business units to ensure compliance with quality systems and drive corporate quality improvement initiatives. Monitoring data and MIS from sites, Data analysis and provide groundwork for strategic decision-making that can guide strategies and improve outcomes. Responsible for creating and implementing all the quality documentation (Quality Manual, FQP, PQP, SOPs, Checklists, Formats, etc.) Provide technical support to the Tendering, Procurement, Engineering and project team as per the need basis. Driving of Kaizen culture across organizations and improving awareness of kaizens through Kaizen training. Digitization of process for improving efficiency and effectiveness Work with project team, Sites, Project academy to identify improvement projects by using Six Sigma, PDCA, 8D, Lean tools etc. Analyze customer complaints, site non conformances thoroughly by use of Quality tools and drive CAPA implementation to improve Quality of construction aiming right first time, zero customer complaint at all sites. Work with Power BI tools, Microsoft Excel, Share point and other power tools to develop quality key metrics dashboard and digital formats Audits at project sites, suppliers to ensure compliance with quality system Drive customer feedback / Voice of Customer program and action plan on customer low score, customer comments to improve customer satisfaction score . Required qualification : B. Tech. (Mechanical/Electrical/ Civil), certified Internal or lead auditor for ISO 9001:2015 or IMS, Experience required : 12 years in Quality & Continuous improvement (after B.Tech.) , Experience in using Microsoft Excel (Proficient) , Share point and Power BI tools Key Interactions : Project Team, Site, Factory, Procurement, CPMG, Project Academy, Tendering team, Engineering, Suppliers, Auditing agencies, Customers, Consultant. Travel Moderate

Role Head Plant QA Position Title: GM/ Senior Manager - Plant Quality Department: Quality Assurance Grade/Level M3 Reporting To: Vice President - Quality Assurance Reportees: 6 - 8 Organisational Chart : Vice President - Plant Operations Key Purpose of the Job (Position Summary) The position is responsible to ensure 100% quality of product as per the plant process standard, thereby eliminating the waste, defectives & rework and rejections. Addressing and resolving in process quality issues raised through customer complaints and improvement of in process quality. The role holder is also responsible to implement quality initiatives, improvement activities and special projects at the plants in alignment to quality strategy and guidelines. KEYPERFORMANCE AREAS Adherence to the plan for sampling, inspection and testing Ensure reduction in rejection Ensure timely resolution of customer complaints Ensure reduction of claims Ensure timely and effective process and product audit Ensure implementation of improvement projects KEY ACTIVITIES & RESPONSIBILITIES Strategy & Planning: Implement strategies for the plant quality in consultation with Quality head Initiate, design & implement quality processes & systems in a structured manner. Carry out planning for department on line with function s objectives. Keep abreast with the national & international quality standards. Identify, plan and initiate investment requirements e.g., quality tools, testing facility, systems etc. Install effective processes & standardize for defect free output from production. Plant Quality Assurance Develop, implement and manage quality control / quality assurance activities in the plant to maximize product quality and customer satisfaction through effective preventive controls Monitor quality practices and procedures being implemented to ensure conformity to quality assurance and safety standards. Review the quality standards regularly based on customer requirements and feedback. Develop, maintain and review quality control charts & database. Create documents and implement inspection criteria and procedures. Train sectional heads in quality systems, tools and techniques to ensure that quality becomes way of working Implement projects to address quality gaps / defects identified and ensure standardization of resolution in processes, as applicable Develop new process / testing techniques and introduction of new methods to ensure quality and cost control Plant Quality Management Drive the interim and final product audit and testing process Work closely with section supervisors to plan, schedule and implement QA related activities. Participate in plant level discussion to draw up action plans to arrest quality rejection occurrences Conduct Why-Why Analysis and create /update control plans regularly Conduct Root cause analysis and take corrective actions to avoid repeat of chronic errors Give recommendations to the Production and the R&D on specific quality parameters and non conformities to assist in development of new components, parts or products. Create and implement a system to ensure product quality traceability throughout the process flow Ensure Quality checks are conducted for all inward material/products in coordination with the Purchase team. Supervise in-process quality checks at every step of the process to ensure that the products are produced as per customer specified dimensions and standards. Inspect finished products to check if they meet the desired quality standards as specified by the customer. Participate in the new product development process by ensuring quality parameters are checked Customer support Monitor and manage customer complaints and provide corrective action to avoid recurrences. Investigate the technical aspects of customer complaints and provide reports to Plant Head for remedial actions. Participate in quality related discussions with Customers and facilitate cascading of the concerns to line heads and other stakeholders in plant Support the Plant Head in discussions with the customers to resolve disputes with respect to customer rejections Address customer complaints leading to warranty claims due to gaps in production processes through study, in-depth analysis, process improvements, tools and other techniques Review warranty parts analysis and customer complaints and recommend suitable action Raw material quality Monitor quality of all inward materials such as raw materials, indirect materials and report back to vendors in case of any quality issue. Resolve vendor quality and performance issues by participating in implementation of quality systems at Vendors Conduct sample checks across plants/ locations to assess equipment reliability and check accuracy of results Conduct quality audits and recommend corrective procedures Conduct review with supplier senior management to escalate and close ongoing issues in purchased parts, in consultation with the Plant Head. Systems and Process Develop and maintain QA standards relating to processes and products Monitor QA systems and advise team on system performance publish statistics regarding performance against set goals Track the quality reports generated by the team to identify and track deviations Ensure adherence to Quality systems such as ISO 9001,OHSAS,etc Perform gap analysis between applicable and current ISO standards establish and implement a quality plan to bring the company into ISO compliance Support new product development and continuous improvement and by integrating quality control tools (e.g. Lean, Six Sigma, etc.) into processes MIS and Reports Define standard guidelines and procedures for quality assurance reports and formats Ensure SAP is updated regularly and accurately by the team. Prepare reports and make recommendations for improving overall quality and solving chronic problems Ensure compilation of information on - Quality status, Complaint sample results, Market sample results and major deviations. & Weekly report submission. Ensure documentation of various BIS and ISO 9000 related compliances. Education and Experience Required Education: B.Tech./ BE degree, with relevant certifications in Quality Systems and Standards Experience: 8 - 12 years RPG Group Apply now

Analysis of in-process, raw materials, intermediates API with expertise on HPLC and wet chemistry. To carry out analytical method development and method validation, in-process samples and finished products. To carry out analytical method transfer activity to QC. Trouble shooting of analytical instruments for difficulties faced during day-to-day operations. Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc. Literature Search for development of analytical methods. To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site Hands on experience on Instruments viz., Auto-titrator, HPLC and UV etc. Knowledge of regulatory requirements for different markets (US, EU, Canada etc.) Knowledge on ICH guidelines, forced degradation studies, impurity profile, etc. Your experience and qualifications M.Sc. / M. Pharm./ Ph.D. 4-8 Years relevant experience Sound knowledge of Chemistry and analytical method development, method validation and transfer, Instrumental method of analysis and logical approach for complex generic API. Teva s Equal Employment Opportunity Commitment

Process Auditor Senior Executive: Please enter job description

Lead and actively participate in all phases of the software development lifecycle, including the design, analysis, development, and deployment efforts for multiple enterprise applications projects to tackle sophisticated business problems Deconstruct large, sophisticated problems into manageable and achievable breakthroughs driving streamlined execution by the team Provide technical guidance and mentoring to peers and more junior engineers, helping them overcome obstacles and have growth opportunities Collaborate with EG leaders with vision to architect and build robust applications and thoughtfully choose relevant technologies to evolve EG travel platform Maintain, monitor and improve our solutions and systems with a focus on service excellence; apply industry standards and new technologies to improve efficiency, quality, and system performance Technologies we use: Java, Kotlin, Dropwizard, Spring, React, GraphQL, Docker, Kafka, Cassandra, MongoDB, Qubole, Spark, DataDog, Splunk, AWS cloud Experience and qualifications: Bachelor s or Master s degree in Computer Science or related technical field or equivalent related professional experience 8+ years of p rofessional, post-college Full Stack software development in object-oriented language A self-starter who is consistently looking to innovate and find ways to enhance our customers experience, with ability to own solutions end to end Strong technical proficiency, capable of problem solving and applying critical thinking Experience in applying AI to practical and comprehensive technology solutions and working with Data Scientists. A deep understanding of software design principles, algorithms and data structures and commitment to technical excellence Strong communication skills and highly effective collaborator Able to articulate your ideas to teammates, peers, and leaders, providing details and supporting your ideas with data where applicable Incorporate others input and feedback and strive to find common ground Enjoy and take pride in the work of your team. You focus on the teams success and have a strong desire to lead by example Experience building on cloud infrastructure (AWS preferred) with sound architectural patterns and scalable, cost-efficient production quality systems Embrace change, always open to replacing what you built yesterday with something better today

The Primary role / function of the System Completion Engineer is to plan and execute all System Completion activities in project scope. The role requires the ability to work across global teams, identify and drive problem resolution, interface and direct multiple project disciplines (eg safety, cost, schedule, quality, systems completion etc), and communicate clearly to site teams, management, and contractor organizations in support of smooth transition from construction to operations. This role requires strong leadership, technical expertise, and problem-solving skills to drive successful project delivery. What will you do Prepare commissioning and start-up sequence, schedules and communicate/drive area completion strategies and system priorities. Develop/Review systems completion plans, startup plans, commissioning procedures, and startup procedures. Oversee and train resources in the establishment, configuration and administration of Systems Completion Database (SCDB) Receive and compile engineering tag lists and ensure correct systemization and hierarchy assignment in systems Completion Database Support development of check sheet and certificate templates and a tag type population matrix Revise and maintain Systemization Guidelines and receive, review, develop or maintain sub-system boundary drawings on behalf of projects. Support comparison of Contractor proposed Inspection Test Records (ITR) and standard reference A-check sheet templates. Prepare mechanical completion, commissioning, and start-up progress reports including Skyline reports, check sheet run-down reports, certification rundown reports, punch list rundown reports. Support punch list walk down package development using redline drawings. Prepare loop folders, work packages and completion dossiers. Preferred Qualifications/ Experience Owner /operator Company experience is highly preferred. Strong leadership, influencing, and interpersonal skills. Able to articulate technical issues to a non-technical audience. Good command of English both written and spoken. Strong organizational, coordination, planning, and interface skills. Knowledge of industry standards and related work processes. Flexibility to travel internationally. Skills & Qualifications: Minimum 3 years of experience supporting Systems Completion in an Owner s organization or experience in Oil & Gas / Chemicals operations. Engineering degree from a recognized university with CGPA 6.5 and above. Working understanding of project completions and commissioning practices. All candidates are expected to have: Strong leadership, influencing, and interpersonal skills. Able to articulate technical issues to a non-technical audience. Good command of English both written and spoken. Strong organizational, coordination, planning, and interface skills. Knowledge of industry standards and related work processes. Owner /operator Company experience highly preferred. Proficiency in MS Word, Excel, and presentation tools. Preferred qualifications Experience with auditing quality management systems is preferred. Certification in auding and in inspection disciplines is preferred Strong presentation skills in English and MS Excel Strong organizational, coordination, planning and interface skills Strong verbal and written communication skills in English Willing and able to travel, as required, for extended periods Your benefits Competitive compensation Medical plans, maternity leave and benefits, life, accidental death and dismemberment benefits Retirement benefits Global networking & cross-functional opportunities Annual vacations & holidays Day care assistance program Training and development program Tuition assistance program Workplace flexibility policy Relocation program Transportation facility

20+ years of relevant Experience with more than 15 years in a reputed organization in a similar role. Certifications CSWIP or equivalent welding certification is must Proficiency in Welding, Heat treatment and metallurgy is a must. Level II Certifications in PT, MT, RT and UT under ASNT is must. Mandatory Requirements: - Exposure in Pressure vessel fabrication as per ASME, EN and other international codes Exposure in inspecting ASME Code Stamped equipment. In-depth knowledge of fabrication practices, QC methodologies, witnessing equipment pressure testing and final inspection Should be conversant with Heat Treatment and related requirements for pressure vessels and heat exchangers as per ASME / API. In-depth knowledge and experience in Quality Control aspects of Raw Materials, Receiving Inspection, Fabrication Inspection, Final Inspection and Documentation Experience of working on materials like Low alloy steels, stainless steels, Inconel etc Should be conversant with ISO 9001 Quality Systems Requirements.

Will lead product RD Change Controls and analytical activities (VV) in order to execute global, cross-functional projects pertaining to polymeric materials Will lead the Change Control m Will utilize their expertise in polymers and polymeric composites, evaluation of material properties to carry out root cause analyses for observed field or manufacturing issues Will develop materials and mechanical testing and verification test protocols, evaluate test cases and create test reports will organize and present technical work and deliverables to the global project team(s) in a we'll-planned manner with a clear logical flow Will perform project management which will typically include managing change controls -using Baxter s in-house quality systems like TW8, TcU Will have to study and understand chemical analysis data such as, FTIR, NMR, ICP-OES methods etc, along with an interpretation of results from mechanical testing of materials, such as, tensile testing Will leverage their own expertise as we'll as inputs from others to identify and resolve critical issues Will perform troubleshooting and problem-solving efforts related to material aspects of the products associated with field performance and manufacturing Will provide project management with an ability to drive materials and VV tests in a timely manner across a number of global, cross-functional projects Qualifications Masters degree in Polymer Science/Engineering or related fields with 7+ years industrial work experience or Ph.D. in Polymer science/Engineering or related fields with 4+ years of industrial work experience. Demonstrated industrial experience in working with polymeric materials and polymer composites - especially in the areas of design, testing (material behavior and component-level validation) and RCAs Clear and effective communication (written, oral) and presentation skills. Good stakeholder management (local and global) A proven track record of effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables Skills Excellent English verbal and written communication skills. Proficient with polymeric materials testing methodologies, such as, DSC, FTIR, GC-MS, HPLC, tensile testing etc Self-directed, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Very adept at grasping and solving complex problems using root-cause analysis techniques. Ability to objectively identify technical solutions and make sound decisions. Solid computer skills: email, documentation and collaboration tools: eg WebEx, Teams, Microsoft Office products, etc Hands on experience in polymeric material s testing and/or CAD/FE packages for design analysis of polymer components is an added advantage

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

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 c ontrols, 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, Supply Chain, Risk Management, Project Manager, Research, Operations, Finance, Technology

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India. Responsibilities: Support the Quality Systems Manager in the management of AliveCor s QMS Maintain AliveCor s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation. Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records. Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies . Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks) Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures. Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure. Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards. Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance. Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed Requirements: Bachelor s degree in Science or Engineering 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.). Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus Excellent organisational skills along with strong attention to detail Ability to work both independently and collaboratively with small, cross-functional teams Highly proficient with Microsoft Office Suite and Adobe Acrobat Perks and benefits: We strive to make your life outside work as smooth as possible while youre at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

Establish control quality budgets for investments, personnel, laboratories & measuring equipment control within the plant. To maintain and improve the QM system, Quality awareness and practices. Required Candidate profile Establish Quality education and training like Core tools and Technical topics. Experience with Quality tools- APQP/ SPC/MSA/FMEA/PPAP and customer specific requirements across Automotive Industry.

Job Description Summary As a Customer Service Engineer, you will be responsible for developing and maintaining strong interpersonal relationships with customer representatives, carrying out installation and maintenance all GE HealthCare Imaging equipments like CT, Cath Lab, C-ARMs, MRI, PETCT, Cyclotron, Ultrasound etc. and ensuring customer satisfaction in the assigned area. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. tex Job Description Roles and Responsibilities: Technical: Maintaining all models specific to Multi-Modality Imaging Equipment in the assigned area. Total system level troubleshooting on complex multi-symptom problems Customer satisfaction: Daily interface with doctors and technicians on equipment status issues. Acts to ensure satisfaction to primary customers Business growth: Assists in the growth and direction of business in his/her geographic area Productivity: Responsible for Warranty and PMS contract cost control Administration: Responsibly completes all administration tasks on time. Ensures timely completion of FMIs and PMS inspections documentation for assigned accounts Installation: Plays a leading role in complex and multifunctional rooms Shares best practices. Maintain effective quality systems and programs compliant with ISO 9001 standard, according to the GEHC Service Quality Policy Statement Assists in account sales visits; helps train others where necessary; identify sales opportunities and communicate to account team Required Qualifications: Bachelor s degree in electrical & electronics Engineering, Biomedical Engineering, Instrumentation Engineering, or related field and 2+ years of experience in servicing medical equipments (Preferably CT/Cath Lab/MR/PET-CT/X-ray/Cyclotron/ Ultrasound, etc) Experience interfacing with both internal team members and external customers as part of a solution-based service process Experience diagnosing and repairing mechanical, electromechanical, and/or electronic equipment Ability to be available after-hours and/or work a rotating on-call schedule, including weekends Sought by others for guidance and advice. Proficiency in English. Ability to work independently with minimum direction High work standards and quality Initiative and motivation. Plans and organizes work effectively Excellent communications, listening and interpersonal skills Strong Customer skills; deals tactfully and effectively with differences of opinion, influences rather than directs Desired Characteristics: Strong oral and written communication skills. Ability to document, plan, market, and execute programs Candidate has to be flexible to work in any location thats assigned to him depending on business requirements

Ensure to give best-in-class service to customer through: ASP (Authorized Service Provider) / ASC (Authorized Service Center) / Ensure Key Service Deliveries like TAT, Customer NPS, Customer satisfaction, Productivity are met consistently Monitor the performance of service centers with strong periodic review mechanism Ensure to manage service center inventory as per MSL & credit limits across all service centers Ensure to generate service revenue through AMC Sale, SPD Sale & Accessory Sale Ensure to keep trained field technician / field service engineer at all service center location in adequate quantity Ensure no escalation from trade & end customers Ensure planned visits to trade & resolve issues timely & maintain good market reputation Monitor successful implementation of quality systems and standards in the service departments. Responsible For Service revenue / Per Call Revenue/AMC Responsible to Solar Service operation / Project handling .

Jobs categories Language 1 company, 4 business lines Jobs categories Language As a member of the IBA family and acting as a leading player in the field of Quality Assurance in Radiation Therapy and Medical Imaging, IBA Dosimetry continuously innovates solutions that enhance quality and outcome of cancer treatments. Our products are distributed worldwide and we are very proud of our international cultural diversity. Employees from over 30 different nations come to work every day sharing the same passion for developing product solutions that protect, enhance and save lives. You consider yourself as a professional in your field yet you are also eager to learn continuously. Team spirit is part of your genes and new challenges boost your motivation. Responsibilities Systematically troubleshot, solve, and document customer complaints related to product issues by leveraging equal parts intuition and technical acumen. Routine follow-ups to ensure resolution and customer satisfaction. Communication with customers related to handling customer s requests and complaints, providing answers and solutions in timely fashion and in accordance with implemented process. Manage and dispatch all incoming customer communications (calls and emails) from both external (end users and distributors) and internal users in a timely fashion. Acquire deep product knowledge (technical and physics related) with the goal of providing comprehensive responses to customer queries. Maintain detailed records of customer interactions, process customer accounts, and file documents. Escalate complex customer issues to appropriate support teams. Follow communication procedures, guidelines, and policies. Recommend potential products or services to management by collecting customer information and analyzing customer needs. Remain continually informed and ready to deploy newly acquired knowledge towards resolution of new issues that may stem from recent product updates or newly discovered bugs. Requirements Master s degree in Medical Physics from a recognized institution or Dip R.P from BARC(Govt. of India). Clinical experience is most preferred. Intermediate familiarity with MS-Office Suite Excel, Powerpoint, Word, etc. Familiarity with applicable Medical Device Quality Systems (FDA, ISO). Basic knowledge of IT and networking fundamentals In depth-networking knowledge and/or certification (e.g Cisco) is a plus. Proficiency in spoken and written English. Affinity for teamwork and well-developed interpersonal skills. Ability to learn and apply newly acquired product training quickly. Willingness to work nights, up to 33% of workdays. Self-driven mindset and ability to work independently Devotion to customer success and a desire to put things right in under tight timeline

? Job Description: ? ? We are seeking for a motivated and detail-oriented QC Trainee / Executive to join our quality team. The ideal candidate will be responsible for supporting quality control operations in method development, routine analysis, and documentation for APIs and intermediates under development. ? ? Key Responsibilities: ? ? Perform sampling and testing of raw materials, intermediates, and finished products. ? ? Conduct instrumental analysis (HPLC, UV, IR, GC) as per approved methods. ? ? Prepare and maintain Certificates of Analysis (COAs), logbooks, and test records ? ? Maintain lab notebooks, data integrity, and QC documentation ? ? Support in creating analytical method to identify, quantify and monitor impurities and the quality of the product ? ? Work closely with R&D and QA teams ensure compliance ? ? Requirements: ? ? 0 1 years of relevant experience in QC role. ? ? Familiarity with laboratory instruments and quality systems. ? ? Basic understanding of analytical techniques and GLP/GMP concepts ? ? Basic understanding of data integrity and GLP practices and Willingness to work in shifts (if required). ? ? Strong attention to detail and documentation skills. ? ? Willingness to learn, good observation skills, and attention to detail ?

Back to search results Previous job Next job JOB DESCRIPTION Company Profile Overview Since year 2003, Oceaneering s India Center has been an integral part of operations for Oceaneering s robust product and service offerings across the globe. This center caters to diverse business needs, from oil and gas field infrastructure, subsea robotics to automated material handling & logistics. Our multidisciplinary team offers a wide spectrum of solutions, encompassing Subsea Engineering, Robotics, Automation, Control Systems, Software Development, Asset Integrity Management, Inspection, ROV operations, Field Network Management, Graphics Design & Animation, and more. In addition to these technical functions, Oceaneering India Center plays host to several crucial business functions, including Finance, Supply Chain Management (SCM), Information Technology (IT), Human Resources (HR), and Health, Safety & Environment (HSE). Our world class infrastructure in India includes modern offices, industry-leading tools and software, equipped labs, and beautiful campuses aligned with the future way of work. Oceaneering in India as well as globally has a great work culture that is flexible, transparent, and collaborative with great team synergy. At Oceaneering India Center, we take pride in Solving the Unsolvable by leveraging the diverse expertise within our team. Join us in shaping the future of technology and engineering solutions on a global scale. Position Summary Position Summary and Location To provide support with our Windows 11 rollout project. Additionally, the technician will assist with end-of-life hardware replacements scheduled for 2025. Duties And Responsibilities Duties and Responsibilities Good analytical and troubleshooting abilities Good understanding of installations and updates Floor walking activities to support Deployment activities Assist in training end-users during all upgrade phases Must have 1 year of MS O365 and Windows 10/11 experience Provide hand-off to other service delivery areas prior to project closure Carry out work in accordance with the Company Health, Safety, Environmental and Quality Systems. Take on other duties as assigned from time to time. Assist in IT Client Services Support for all Oceaneering Offices. Other special duties as assigned by Management. Ensure that the safety policies and procedures are understood and adhered to as far as is reasonably practicable in order to ensure a safe working environment. Safety Ensure that the Safety policies and procedures are understood and adhered to so far as is reasonably practicable in order to ensure a safe working environment. Other Carry out work in accordance with the Company Health, Safety, Environmental and Quality Systems. Perform the assigned tasks with due diligence regarding the Integrated Management Systems on the Company. Eliminate waste of whatever form, to suggest the use of more environmentally friendly substances and practices and contribute to the continuous improvement of the environment. Supervisory Responsibilities This position does not have direct supervisory responsibilities. Reporting Relationship Reporting to Manager I, Client Services, Grade II Qualifications Qualifications REQUIRED Minimum BS degree in a related field (i. e. computer science, MIS, etc. ) 1 year of experience as a Tier II technician, including 1 year of hands-on experience with Hardware/Software application and Windows 10 & Windows 11 OS installation, configuration, and troubleshooting Experience with Microsoft Azure Strong written and verbal communication skills. Knowledge of Hardware/Software troubleshooting Knowledge, Skills, Abilities, and Other Characteristics Office 365 Active Directory Should have hands-on experience with Hardware/Software application and Windows 10/11 OS installation, configuration, and troubleshooting Must be a self-starter with the ability to work independently and in a collaborative team environment. Practical knowledge of Active Directory Federation Service, Azure and O365 solutions (SharePoint online, OneDrive, Teams, Planner etc. ) Quickly respond to technical assistance requests and excellent people skills with ability to handle difficult personnel situations. Additional Information Working Conditions This position is considered OFFICE WORK which is characterized as follows. Almost exclusively indoors during the day and occasionally at night Occasional exposure to airborne dust in the workplace Work surface is stable (flat) How To Apply Equal Opportunity/Inclusion Oceaneering s policy is to provide equal employment opportunity to all applicants. How To Apply Career Development In addition, we make a priority of providing learning and development opportunities to enable employees to achieve their potential and take charge of their future. As well as developing employees in a specific role, we are committed to lifelong learning and ongoing education, including developing people skills and identifying future supervisors and managers. Every month, hundreds of employees are provided training, including HSE awareness, apprenticeships, entry and advanced level technical courses, management development seminars, and leadership and supervisory training. We have a strong ethos of internal promotion. We can offer long-term employment and career advancement across countries and continents. Working at Oceaneering means that if you have the ability, drive, and ambition to take charge of your future-you will be supported to do so and the possibilities are endless. Add To Cart

KRA's: Quality check of all raw materials, in-process and finished goods on a FIFO basis QMS Implementation Audit Documentation Internal/ external as well as 3rd party/ regulatory audit compliances Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a medical device/ pharmaceutical manufacturing co. Should be ready to travel or relocate to Taloja Navi Mumbai

KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided

Lead quality initiatives & drive continuous improvement Develop & implement quality strategies Conduct regular audits & inspections. Ensure compliance with industry standard Ensure that products meet quality standards and customer expectations.

At American Express, you ll be recognized for your contributions, leadership, and impact every colleague has the opportunity to share in the company s success. Together, we ll win as a team, striving to uphold our company values and powerful backing promise to provide the world s best customer experience every day. And we ll do it with the utmost integrity, and in an environment where everyone is seen, heard and feels like they belong. Join Team Amex and lets lead the way together. What to Expect: Should be proficient with defining technical solution based on problem in hand Identify opportunities for further enhancements and refinements to standards and processes. Fine tune the existing technology with new ideas and optimization opportunities. Should be able to define solution scoping and effort sizing within a cross-functional team Serving as a core member of an Engineering team help and guide the team in end-to-end delivery Effectively interpreting technical and business objectives and challenges and articulating sound solutions. Provide technical expertise in driving projects from inception to closure Perform code reviews, design reviews and help the team to produce high quality systems. Research: stay informed on technology trends. Join us if you have: Bachelor s degree in engineering or computer science or equivalent OR master s in computer applications or equivalent 5+ years of experience in automation testing using API automation, Java, Selenium, Playwright, Cucumber.js Good understanding of automation testing paradigms for frontend, middlewares, and microservices Good understanding of deployment strategies, change management, and application monitoring for quality control. : Competitive base salaries Bonus incentives Support for financial-well-being and retirement Comprehensive medical, dental, vision, life insurance, and disability benefits (depending on location) Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need Generous paid parental leave policies (depending on your location) Free access to global on-site wellness centers staffed with nurses and doctors (depending on location) Free and confidential counseling support through our Healthy Minds program Career development and training opportunities.

Position summary statement Join Herbalife International as an Assistant Manager, Quality Food Safety and play a vital role in ensuring our products meet the highest quality standards. This outstanding opportunity offers the chance to work with a world-class team dedicated to excellence in manufacturing, storage, and transportation of raw and packing materials. You will be instrumental in maintaining our strict global procedures, ensuring flawless compliance with Herbalifes Quality or equivalent experience and Food Safety requirements throughout the value stream. As an Assistant Manager, you will coordinate various Quality Assurance (QA) activities on-site, ensuring our products are safe and of outstanding quality. Your role will involve managing Food Safety Management Systems (FSMS), conducting audits, and training teams to achieve our ambitious quality goals. Responsibilities Ensure compliance with regulatory requirements in all stages of product development and manufacturing. Coordinate the implementation of Global Policy Requirements into Herbalife India SOPs and actual practices. Assure that all QA documents meet established Global, India corporate, and regulatory standards, ensuring they are efficient and effective systems for both their use and Quality Assurance. Perform regular reviews and assessments of processes, procedures, and systems to ensure ongoing compliance. Supervise and track quality metrics to identify any deviations and work on corrective actions. Conduct gap analysis for Global policies, India level documents, and regulatory requirements applicable to CMs, and develop action plans to close gaps and mitigate risks. Compile all materials required for regulatory submissions, license renewal, and registrations, staying current with regulatory procedures and changes in quality systems. Regularly interact with collaborators, customers, partners, and team members to meet ISO/FSSC 22000, HACCP, and FSSAI requirements at the manufacturing facility. Maintain up-to-date documentation related to quality and food safety compliance activities, including audit reports, corrective actions, and regulatory submissions. Prepare and submit compliance reports to senior management as needed. Education Graduation or Post Graduation in Food Technology, Food Science, Pharma, or other allied streams. Skills FSSAI Certification HACCP Certification ISO 22000 or FSSC 22000 Certification GMP Training Experienced or trained in Food Safety Management system implementation. Proficient in Microsoft Office (Word, PowerPoint, Excel). Excellent interpersonal skills, both written and verbal. Experience Minimum 10 years of experience in the relevant field. Industry Type Nutraceutical, Pharma, Food, Ayurveda.

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: sector 43, 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 c ontrols, 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 RD, Facilities, Supply Chain, Risk Management, Project Manager, Research, Operations, Finance, Technology

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 RD, Facilities, Project Manager, Risk Management, Supply Chain, Research, Operations, Technology, Finance