- Integra LifeSciences (Mansfield, MA)
- …knowledge of DFSS techniques * 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development * Fluent ... new standards of care. This **Staff Design & Reliability Assurance Quality Engineer** is a key functional...Risk Management (ISO 14971 2019), MDD ( Medical Device Directive), IEC 62366, ISO 13485 ( Quality … more
- Danaher Corporation (Waltham, MA)
- …or a related field. + Experience: Minimum of 5 years in quality assurance within the medical device or related industry. + Leadership Experience: ... agile and above all audacious so we can truly drive science forward. The Quality Assurance Manager is responsible for overseeing an ISO 9001 certified … more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed in accordance with Abbott's design control… more
- Takeda Pharmaceuticals (Lexington, MA)
- …including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are ... **Job Description** **About the Role** As Head of Global Quality Device Compliance for the US and...including stand-alone devices, combination devices, and Software as a Medical Device for the US and Rest… more
- Teleflex (Chelmsford, MA)
- Sr. Quality Assurance Manager **Date:** Jan 5, 2026... Quality System Regulation (21 CFR Part 820), Medical Device Directive/ Medical Device ... a difference in patients' lives. **Position Summary** The Senior Quality Assurance Manager of the Chelmsford Facility...A minimum of 7 years' leadership experience in the medical device industry, with at least 12… more
- Teleflex (Chelmsford, MA)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ... Quality Engineer 2, Product Quality Assurance **Date:** Dec 31, 2025...Engineering (or related technical field) * 2-5 years related ( medical device preferred) experience * Experience with… more
- Hologic (Marlborough, MA)
- …and reliability of life-saving medical devices? At Hologic, we are seeking a ** Quality Assurance Engineer - Product Quality ** to play a critical role ... Quality Assurance Engineer 2 Marlborough, MA,... Quality Assurance Engineer 2 Marlborough, MA, United States Louisville,..., Project Management or Customer Service roles in a medical device or related regulated industry. +… more
- Medtronic (Newton, MA)
- …Collaborate with cross-functional teams, including hardware engineers, product managers, and quality assurance , to define software requirements and deliver high- ... that enhance the usability and functionality of our advanced medical devices. The Principal Software Engineer will be a...code reviews and provide constructive feedback to ensure code quality and adherence to best practices. + Mentor and… more
- Philips (Cambridge, MA)
- …accommodation for this position. + You are adept at engaging with Quality Assurance stakeholders during strategy development, project planning, implementation ... advanced analytics tools, and contribute to innovative solutions that improve the quality of life for patients worldwide. **Your role:** + Analyze complex datasets… more
- Hologic (Marlborough, MA)
- …MA, United States Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking ... a **Lead Design Assurance Engineer** to play a pivotal role in new...to hear from you! **Knowledge:** + In-depth understanding of medical device regulations and standards, including ISO… more