- Stryker (Portage, MI)
- …Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) ... maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards. + Demonstrated strong understanding… more
- J&J Family of Companies (Danvers, MA)
- …verification and validation plan and strategies while maintaining traceability. + Use Software as a Medical Device (SaMD) and Software in a Medical Device ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** R&D/Scientific Quality **Job...of 5 years of related work experience within the medical device industry on SaMD and SiMD… more
- Integra LifeSciences (Plainsboro, NJ)
- …Certifications: ASQ CQE preferred + Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. + ... corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device … more
- Cook Medical (Bloomington, IN)
- …clinical, and regulatory affairs.- Provide leadership in the understanding of medical device regulations and best practices.- Manage conflict resolution ... Overview The Quality Engineer serves as the lead quality...degree and 5-8 years of experience- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and… more
- Stryker (San Jose, CA)
- … Engineer** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) ... strong technical skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …years of experience as a lead inspector or supervisor in an FDA regulated medical device manufacturing environment required. + Must have a strong understanding ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Cook Medical (Bloomington, IN)
- …clinical, and regulatory affairs.* Provide leadership in the understanding of medical device regulations and best practices* Manage conflict resolution ... Overview The Quality Engineer at Cook Inc. serves as the...Engineering, * 3-5 years of experience* Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure ... product development or on design changes to ensure product quality and minimize risk to users and patients as...Overview: This position offers a comprehensive benefits package including medical , dental, and vision insurance, a 401(k) with company… more
- Aerotek (Carlsbad, CA)
- …assembly under a microscope. This role is vital in ensuring the highest quality standards in medical device production. **Responsibilities** + Adhere ... **Job Title: Medical Device Assembly Technician** **Job Description**...understand and perform in-process inspections to assure workmanship and quality of in-process medical devices. **Additional Skills… more
- Abbott (Sylmar, CA)
- …Preferred Qualifications + Fluent in Mandarin + Previous regulatory compliance, R&D, and/or quality experience in medical device industry + Good working ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with… more