• Sr. Manager- Software Design Assurance

    Philips (San Diego, CA)
    …+ You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software Design ... The Sr. Manager-Software Design Assurance will play a critical role in managing/supporting the Software Design Control process for new/existing Image Guide Therapy… more
    Philips (08/09/25)
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  • Medical Devices Software Quality…

    US Tech Solutions (San Bruno, CA)
    …solutions for a person based on a comprehensive view of the evidence. **Responsibilities:** ** Quality Assurance Champion:** 1. Act as a champion of Quality ... ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1....including Google Suite. 2. Experience with diverse tools for quality assurance and engineering tasks, showing adaptability… more
    US Tech Solutions (07/18/25)
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  • Document Control Manager

    Fujifilm (Santa Ana, CA)
    …+ **Bachelor's degree required** + **A minimum of five (5) years of Quality Assurance and or Document Control in a medical device manufacturer or ... 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for...Excel, Novell, Windows 2000 or similar. + Knowledge of Quality Assurance Document Control Systems. + Ability… more
    Fujifilm (09/06/25)
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  • Senior Quality Engineering - Shockwave…

    J&J Family of Companies (Santa Clara, CA)
    …Familiarity 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
    J&J Family of Companies (08/29/25)
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  • Sr. Quality Engineer

    Envista Holdings Corporation (Pomona, CA)
    …The **Sr. Quality Engineer** plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. The Sr. ... closely with cross-functional teams to develop, implement, and maintain quality assurance protocols that comply with regulatory...degree preferred + 5+ years of experience in Engineering; medical device or similar regulated industry highly… more
    Envista Holdings Corporation (06/13/25)
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  • Senior Director, BWI Quality & Compliance

    J&J Family of Companies (Irvine, CA)
    …action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines. + ... profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job… more
    J&J Family of Companies (09/03/25)
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  • Senior Quality Engineer II - Combination…

    Gilead Sciences, Inc. (Foster City, CA)
    …and experience in quality assurance for the development of medical devices and/or drug- device combination products. + Excellent verbal, written, and ... **Job Description** **Key** **Responsibilities:** + Serve as a lead quality engineer for medical device combination product development projects, with a… more
    Gilead Sciences, Inc. (08/12/25)
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  • Sr. Regulatory Affairs Specialist

    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 ... your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide… more
    Caldera Medical (08/24/25)
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  • Director of Product Quality…

    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 ... function requiring technical product expertise (Design Assurance , Quality Operations, etc.) + Experience in full Medical... Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
    BD (Becton, Dickinson and Company) (07/18/25)
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  • Spec, Quality Compliance

    BD (Becton, Dickinson and Company) (Irvine, CA)
    …and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports ... weekly meetings to discuss complaint issues with affected functions (eg, Manufacturing, Quality Assurance , Suppliers, etc.) to identify assignable root cause,… more
    BD (Becton, Dickinson and Company) (08/09/25)
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