- BD (Becton, Dickinson and Company) (San Diego, CA)
- …technology solutions that will mitigate risk + Solid understanding of the medical device and healthcare IT space + Advanced analytical and problem-solving ... of possible!** BD is one of the largest global medical technology companies in the world. _Advancing the world...(Azure, AWS) + Experience in healthcare interoperability or remote device management + Experience navigating and driving… more
- Edwards Lifesciences (Irvine, CA)
- …or related field with 15+ years of relevant Engineering experience with 10+ years in medical device -OR- + Master's degree in engineering or related field with ... 14+ years of relevant Engineering experience with 10+ years in medical device + 5+ years of experience by showing a demonstrated track record in leadership… more
- Actalent (Vista, CA)
- …+ ISO auditing + Quality Management System (QMS) + Quality assurance + Medical device auditing + CAPA (Corrective and Preventive Actions) + Audit ... Quality Management System. + Participate in the Risk Management team, working with team members...management skills + Medical Device ...management skills + Medical Device Reporting (MDR) Additional Skills &… more
- Abbott (Sylmar, CA)
- …engineering, regulatory, human factors, quality, marketing, etc + Provides input to the risk management file and Clinical Evaluation Reports in support of the ... CA or Sunnyvale, CA locations in the Cardiac Rhythm Management Division.** As a global leader in Cardiac Rhythm...or similar + Minimum of 10+ years of clinical medical device experience or equivalent, ideally with… more
- Burns & McDonnell (San Diego, CA)
- … management of projects in the pharmaceutical, biotechnology, animal health and medical device industries. The Project Manager will be responsible for project ... industries of pharmaceutical, biotechnology, animal health, cell & gene therapyor medical device .is preferred. + Excellent written and verbal communication… more
- J&J Family of Companies (Santa Clara, CA)
- …plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports). + Provides direction and ... 21 CFR Part 820, 21 CFR Part 11, European Medical Device Regulation (MDR), and applicable guidance....reviews. + Function as the quality expert in software risk management processes throughout the entire software… more
- CalSTRS (Sacramento, CA)
- …areas: Office of Legal Ethics & Accountability (OLEA), Enterprise Information Management & Legal Operations, Information Security Office, Legal Services, Investment ... and is a subject matter expert on cybersecurity and managing third-party risk technologies, projects, solutions development, and strategy. The incumbent performs a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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...facilitate meetings. + In-depth understanding and execution of Quality Risk Management . + Ability to track and… more
- Wells Fargo (San Francisco, CA)
- …commercialization. The team focuses its efforts on subsectors such as Biotech/Pharma, Medical Device , Digital Health, Healthcare IT, Pharma Outsourcing, and ... require research, evaluation, and exercise independent judgment to guide medium risk deliverables + Present recommendations for growing and maintaining a portfolio… more
- Actalent (Irvine, CA)
- …+ Provide technical guidance and oversight to Quality Engineers. + Participate in Risk Management process, including the development and maintenance of risk ... + Provide key quality trending information and data for Management Review and monthly KPI review, as applicable. +...in Engineering or technical discipline required + 5 Years medical device experience required Knowledge, Skills and… more