- 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...in ensuring the safety and performance of our innovative medical devices . You'll lead hands-on investigations, analyze… more
- Abbott (Pleasanton, CA)
- …Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Stryker (San Jose, CA)
- …skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software ... 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a...+ Partner with cross-functional teams, including marketing, R&D, clinical, regulatory , and operations, to deliver quality , compliant… more
- Abbott (Temecula, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... more than 160 countries. **About Abbott** For years, Abbott's medical device businesses have offered technologies that...tools based on findings. + Ensures sustaining support of Quality System and regulatory compliance by individually… more
- Terumo Neuro (Aliso Viejo, CA)
- …regulations, standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory ... **12870BR** **Title:** Sr Specialist, Clinical Trial Quality Assurance **Job Description:** Provide support to all...standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and experience in quality assurance for the development of medical devices and/or drug- device combination products. **Preferred Qualifications:** ... based on quality principles and theories. + Strong knowledge of medical devices and or combination products manufacturing. + Excellent verbal, written,… more
- Stryker (San Jose, CA)
- …Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to support projects as a quality engineer for post-market activities to drive ... working in the areas of Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory ...strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a… more
- Hologic (San Diego, CA)
- …years of experience in post-market quality assurance within the medical device industry such as medical devices , diagnostics, or pharmaceuticals). + ... Quality Assurance Specialist (Post-Market) San Diego, CA, United...a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices … more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …center. **Knowledge and Skills:** + Quality Management Systems requirements for medical devices + Knowledge and applied experience of 21CFR, MDD 93/42/EEC, ... experience of QA professional and technical staff + Expertise in regulations affecting medical devices marketed in all regions throughout the world. + Expertise… more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... considered. + Min 10 years of experience in the medical device industry + Min 8 years...at www.facebook.com/Abbott , and on Twitter @AbbottNews. **Divisional Information** Medical Devices General Medical … more