- Gilead Sciences, Inc. (Foster City, CA)
- …and review/approve Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance: engage/liaise with ... medical device product engineering, development, and quality teams. + Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality… more
- Astrix Technology (Irvine, CA)
- …+ Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience with medical device complaint handling and regulatory reporting (MDR, Vigilance, ... ** Quality Operations Specialist** Engineering Irvine, CA, US Pay...leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses… more
- Abbott (Sylmar, CA)
- …field (Master's or RAC certification preferred) + 10+ years of progressive experience in Quality Assurance within the medical device or digital health ... portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital...and impact. You will develop and implement a best-in-class Quality Management System (QMS) that supports both medical… more
- J&J Family of Companies (Santa Clara, CA)
- …software development, software verification and validation. + 4 years' experience in a quality role within the medical device , aerospace/defense or similarly ... multiple subject areas to improve patient outcomes and advance medical professionals' skills. The Staff Software Quality ...21 CFR Part 820, 21 CFR Part 11, European Medical Device Regulation (MDR), and applicable guidance.… more
- Abbott (Temecula, CA)
- …serve people in more than 160 countries. **About Abbott** For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...tools based on findings. + Ensures sustaining support of Quality System and regulatory compliance by individually… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manner. + Cross-Functional Collaboration:Establish and model effective engagement pathways between Quality , Device Engineering, Regulatory , and internal and ... of relevant experience. + Demonstrated knowledge and experience in quality assurance for the development of medical ...in quality assurance for the development of medical devices and/or drug- device combination products. **Preferred… more
- Hologic (San Diego, CA)
- …or a related field, or equivalent experience. + 3-5 years of experience in post-market quality assurance within the medical device industry such as ... Quality Assurance Specialist (Post-Market) San Diego, CA, United...a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release.… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …devices marketed in all regions throughout the world. + Expertise in failure investigation and medical device CAPA process. + Experience in medical device ... understanding of design quality assurance. + Lead Quality System auditor experience. + Experience managing regulatory...working in a design center. **Knowledge and Skills:** + Quality Management Systems requirements for medical devices… more
- CTG (Woodland, CA)
- …preferred) **Qualifications** * Minimum 3 years' experience in Quality or Regulatory , preferably in medical device , pharmaceutical, or biotechnology ... Quality Engineer II will develop and support all Quality Management System (QMS) and Regulatory Affairs (RA) activities in alignment with site quality … more
- Hologic (San Diego, CA)
- …experience in a regulated environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR ... as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other… more