- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III devices, or ... for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments... Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
- Abbott (Alameda, CA)
- …discipline. + Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Santa Clara, CA)
- …by providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... Assists management and leadership on regulatory activities and works with the medical device business units that Leverage Services team supports, including… more
- J&J Family of Companies (Santa Clara, CA)
- …Director or above in a quality function across Design and Development including End-to-End Quality & Compliance in Medical Device . + Must have a minimum ... business functions, manage audit/inspection outcomes with Notified Bodies and FDA , lead and drive effective oversight of CAPA Program...of 5 years of large-scale Capital Medical Device Equipment experience as a quality leader… more
- Stryker (San Jose, CA)
- …Microsoft, or similar, demonstrating strong technical skills + Experience with regulatory agencies ( FDA , MoH, TUV) and medical device regulations (820, IEC ... Quality Engineer, Design Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a … more
- J&J Family of Companies (Santa Clara, CA)
- …with FDA guidance documents and ISO and + ASTM standards related to quality and medical device industry. + Independently assesses if components, ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- Oura (San Francisco, CA)
- …digital health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device ... and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and… more
- Abbott (Menlo Park, CA)
- …and IV). + Minimum of 5 years' experience of Risk Management in the Medical Device or Pharmaceutical Industry, preferably focused on complaint management and ... of life through the design and provision of device and management solutions for the treatment of structural...plus years of progressively more responsible work experience in quality assurance and design related to medical … more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. 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...help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with… more
- Abbott (Sylmar, CA)
- …Electrical/Computer Engineering + Software Quality Engineering experience + Prior medical device experience preferred. + Knowledge of Cybersecurity and Data ... typical to meet the skills and responsibilities of the position. + Knowledge of FDA Quality System Requirements and other applicable US Code of Federal… more