- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... design and development. **Essential Job Functions** + Design and develop software for medical device product(s) in full compliance with the company's Design… 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:** + Prior ... + Cross-Functional Collaboration:Establish and model effective engagement pathways between Quality , Device Engineering, Regulatory, and internal and external… more
- Abbott (Pleasanton, CA)
- … quality -related issues in a timely and effective manner + Prior medical device experience preferred + Experience implementing various product and process ... + 5+ years related work experience + Engineering experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA , GMP, ISO 13485, and… more
- Abbott (Pleasanton, CA)
- …Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other similarly regulated environment. ... + Analyze trends from various sources and proactively address regulatory, compliance, and quality issues. + Actively participate in FDA inspections and lead… more
- Astrix Technology (Irvine, CA)
- …reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part ... Rate High: 35 + Added - 05/02/2025 Apply for Job Our client is a Medical Manufacturing company enhancing vision and improving quality of life through innovative… more
- Envista Holdings Corporation (Pomona, CA)
- …related field; Master's degree preferred + 5+ years of experience in Engineering; medical device or similar regulated industry highly preferred + Strong ... QUALIFICATIONS:** + Experience with statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation… 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...Quality System. (eg compliance with internal procedures and FDA , BSI regulations etc). + Interacts with internal and… more
- Actalent (Irvine, CA)
- …+ Bachelor's Degree in Engineering or technical discipline required + 5 Years medical device experience required Knowledge, Skills and Abilities + Proficient ... test equipment + Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing + Working knowledge of EN ISO 13485, ISO… more