- Integra LifeSciences (Boston, MA)
- …instructions precisely, recognize deviations, and recommend corrective action. + Certified Quality Engineer preferred, but not required. Integra LifeSciences is ... possible and making headway to help improve outcomes. The Engineer II, Quality will be responsible for...results of risk analysis + Support as required the Quality Management Review Process + Participate in FDA… more
- Neotech (Westborough, MA)
- Summary: The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interacting ... quality process including FMEA. * Work with process engineer and other team for product & process validation...and maintenance to it is compliant to customer requirements, FDA regulations and ISO specifications. * Ensure the production… more
- J&J Family of Companies (Boston, MA)
- Quality Engineer II, Product Software Development...regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU ... a member of Johnson & Johnson Family of Companies, is recruiting for a Quality Engineer II, Product Software Development to be located in Boston, MA, Raynham, MA… more
- Fresenius Medical Center (Lawrence, MA)
- Software Quality Engineer II, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care NA company, Lawrence, Massachusetts (Remote) **Purpose and Scope:** ... quality systems are compliant with Fresenius procedures, FDA Quality System Regulations, 21 CFR Part...of experience as a Software Developer or Software QA Engineer . Must have had 1 year of experience (which… more
- Integra LifeSciences (Boston, MA)
- …in the Medical Device or similar FDA regulated industry. + Certified Quality Engineer preferred, but not required. **TOOLS AND EQUIPMENT USED** Ability to ... and making headway to help improve outcomes. The Sr. Engineer II, Quality is responsible for providing...analysis. + Working knowledge of medical device regulations (including FDA QSRs, ISO13485). + Ability to communicate effectively (both… more
- Fresenius Medical Center (Lawrence, MA)
- …IT to ensure that computerized quality systems are compliant with FMCNA procedures, FDA Quality System Regulations, 21 CFR Part 11, and GAMP5. + Leads and ... degree 3 years of experience may be acceptable. + Thorough understanding of FDA Quality System regulations in relation to computer system validation + ASQ CSQE… more
- Teleflex (Chelmsford, MA)
- Senior Quality Engineer **Date:** Apr 5, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :10020 ... solutions that make a difference in patients' lives. **Position Summary** The Sr. Quality Engineer will be responsible for cross-functional quality … more
- Teleflex (Chelmsford, MA)
- Quality Engineer II, Design Assurance **Date:**...industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab ... lives. **Position Summary** As a member of a cross-functional team, the Quality Engineer , Design Assurance is responsible for quality throughout new product… more
- Bausch + Lomb (Wilmington, MA)
- …performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred. + Lean manufacturing / Six Sigma helpul ... manufacturing or industrial environment. + Strong working knowledge of FDA / ISO 13485 Quality System. requirements,...working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and… more
- Integra LifeSciences (Boston, MA)
- …what's possible and making headway to help improve outcomes. **SUMMARY DESCRIPTION** The Sr. Engineer II, Quality is responsible for providing quality and ... results of risk analysis, * Support as required the Quality Management Review Process * Participate in FDA... Quality Management Review Process * Participate in FDA inspections, ISO Certification and surveillance audits and customer… more
- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** The Senior Supplier Quality Engineer , Software is responsible for the product-related supplier ... for software controls. **Job Duties** + Acts as supplier quality engineering representative in new product development projects +...Quality tools and methods + ISO 9001 I FDA I Medical technology background + Basic project management… more
- Olympus Corporation of the Americas (Westborough, MA)
- …our core values by staying **True to Life.** **Job Description** The Senior Supplier Quality Engineer is responsible for the product-related supplier quality ... handling and incoming inspection planning. **Job Duties** + Develops quality assurance strategy for sourced products including suppliers and...Quality tools and methods + ISO 9001 I FDA I Medical technology background + Basic project management… more
- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** The Principal Design Assurance Engineer will focus on Product Quality by contributing to new product ... issue escalations Supports facility audits by outside agencies (ie, FDA , ISO / MDSAP). + Other Quality ...(ie, FDA , ISO / MDSAP). + Other Quality Assurance responsibilities as assigned by Management **Job Qualifications**… more
- Fresenius Medical Center (Lawrence, MA)
- …Software . Understanding of how Agile Software Development practices work with the FDA /EU Quality . Creative problem solving . Windchill and Polarion software ... (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that… more
- Medtronic (Danvers, MA)
- **Careers that Change Lives** In this exciting role as a Supplier Quality Engineer II, you will have responsibility for supporting the quality standards of ... location. **A Day in the Life** As the **Supplier Quality Engineer II** , you will: +...ASQ CSQP and/or CQE Certificate + ISO 13485 and FDA 21CFR820Training + CAPA Training + Microsoft Suite Training… more
- Abbott (Westford, MA)
- …Our location in Westford, MA, currently has an opportunity for a Design Quality Engineer . **The Opportunity** This position works out of our Westford, ... A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for… more
- Integra LifeSciences (Billerica, MA)
- …us are challenging what's possible and making headway to help improve outcomes. ** Quality Engineer , Senior, Design & Reliability Assurance** The Senior Design ... Assurance Engineer will be responsible for supporting New Product Development...including R&D, Supply Chain Operations, Manufacturing, Procurement and Operations Quality . + Responsible to establish Design Assurance requirements and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA). + Working knowledge ... values by staying **True to Life.** **Job Description** Provide Quality Engineering support to ensure compliance with the ...of metrology. + Requires background and familiarity with US FDA QSR requirements including ISO 9001 MDD 93/42 ISO… more
- Teleflex (Chelmsford, MA)
- Sr. Supplier Quality Engineer **Date:** Apr 3, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 25% **Requisition ID** ... provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless… more
- Abbott (Westford, MA)
- …location in **Westford, MA** currently has an opportunity for a **Staff Software Quality Engineer ** **.** **THIS IS AN ON-SITE DAILY POSITION.** **WHAT YOU'LL ... Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement… more