- Actalent (Irvine, CA)
- …with our medical devices. The ideal candidate will have strong experience in quality systems within the medical device industry and a proven ability ... of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Strong understanding of FDA regulations and other relevant… more
- Abbott (San Diego, CA)
- …(IDEs, debuggers, unit test frameworks) + Knowledge of design controls and regulations for medical device development is a plus + Understanding of quality ... visual modeling, multi-threading, formal development methodologies, and source code management + Medical device product development knowledge is a plus + Ability… more
- Abbott (Milpitas, CA)
- …in model based design (UML or SysML), is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …planning for marketing collateral to support clinical products + Ownership of on-time quality assessments, medical device reporting and health risk ... bodies + Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory bodies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BRH solutions, particularly in regulated environments such as pharmaceutical, biotech, or medical device manufacturing. + Experience with SAP S/4HANA and ... SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and...time off, and a benefits package. Benefits include company-sponsored medical , dental, vision, and life insurance plans*. For additional… more
- Terumo Medical Corporation (San Francisco, CA)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Abbott (Sylmar, CA)
- …skills, including statistical/data analysis and report writing skills. + Prior medical device experience preferred. + Experience implementing various product ... supervisory experience preferred. + Engineering experience and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO… more
- Kelly Services (Petaluma, CA)
- …a Director of Operations and Manufacturing on behalf of our client in the medical device and pharmaceutical industry. This is a key leadership role reporting ... least 5 years in a leadership role within the medical device or pharmaceutical industry. + Strong...device or pharmaceutical industry. + Strong knowledge of FDA regulations, including 21 CFR Part 820. + Proven… more
- Caldera Medical (Westlake Village, CA)
- …is Caldera Medical ? Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera ... Analyst 100% ONSITE - in Westlake Village, California Caldera Medical 's Mission - To Improve the Quality ...requirements. * Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or equivalent regulatory… more
- Actalent (Irvine, CA)
- …+ Quality assurance + Root cause analysis + Audit + Medical device investigations + CAPA's + FDA regulations + Risk mitigation + NCMR + Product ... Job Title: Quality EngineerJob Description The Quality Specialist...is based in an on-site manufacturing environment where innovative medical products and services are developed, manufactured, and marketed… more