• Staff Quality Auditor

    Abbott (Alameda, CA)
    …conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations ... medicines. Our 114,000 colleagues serve people in more than 160 countries. **Staff Quality Auditor** **Working at Abbott** At Abbott, you can do work that matters,… more
    Abbott (06/29/25)
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  • Regulatory Engineering Specialist

    Kelly Services (Petaluma, CA)
    …results without heavy oversight. **What You'll Do** + Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and process ... Engineering Specialist** who can bridge the gap between engineering, quality , and regulatory functions. This role is ideal for...changes. + Prepare and support FDA submissions, including Class I device registrations, Class II… more
    Kelly Services (08/26/25)
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  • Supplier Engineer

    Caldera Medical (Westlake Village, CA)
    …* Preferred: knowledge of extrusion, injection molding, and metal forming. * Experience with quality systems meeting FDA QSR, ISO 13485, MDD, GMP, and GDP ... is not available for this role. Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: The Supplier Engineer is… more
    Caldera Medical (08/24/25)
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  • FSP - Research Scientist - Analytical Development…

    ThermoFisher Scientific (San Diego, CA)
    …Familiar with degradation pathways and forced degradation studies. + Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1. + ... and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people...Experienced user for document management systems such as Veeva Quality and Veeva RIM. + Supports Quality more
    ThermoFisher Scientific (08/23/25)
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  • Sr Quality Compliance Manager

    Abbott (Pleasanton, CA)
    …+ Analyze trends from various sources and proactively address regulatory, compliance, and quality issues. + Actively participate in FDA inspections and lead ... to restore their health and get on with their lives. As a Senior Quality Compliance Manager, the individual will play a crucial role within Abbott's Heart Failure… more
    Abbott (06/19/25)
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  • Principal R&D Engineer (Sustaining) - Shockwave

    J&J Family of Companies (Santa Clara, CA)
    …to company's products. + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. ... regulatory requirements. + Ensure proper documentation consistent with company's quality system. + Responsible for knowing and planning activities consistent… more
    J&J Family of Companies (08/28/25)
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  • Senior NPD Manufacturing Engineer

    Stryker (San Jose, CA)
    …Bachelor's in Engineering + Knowledge of applicable domestic and international regulations and quality system standards - FDA QSR, MDD, ISO13485, ISO9001, etc. + ... accordance with the Stryker new product and service development procedures. + Ensure quality of process and product as defined in the appropriate operation and… more
    Stryker (08/19/25)
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  • Production Lead

    PRIDE Industries (Auburn, CA)
    …Division 104, Part 5 - Sherman Food, Drug and Cosmetic Law: 2008, and FDA 's Quality System Regulations, preferred; * Knowledge of planning, forecasting, and ... mission: To Create Jobs for People with Disabilities while providing high quality , value-added solutions to our nationwide customers. We are currently recruiting to… more
    PRIDE Industries (08/14/25)
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  • Principal R&D Engineer - Shockwave Medical

    J&J Family of Companies (Santa Clara, CA)
    …products being developed. + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. ... regulatory requirements. + Ensure proper documentation consistent with the company's quality system. + Responsible for knowing and planning activities consistent… more
    J&J Family of Companies (08/13/25)
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  • Principal R&D Engineer (Balloon Tech) - Shockwave

    J&J Family of Companies (Santa Clara, CA)
    …to company's products. + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. ... proper documentation (eg, component and assembly drawings) consistent with company's quality system. + Responsible for knowing and planning activities consistent the… more
    J&J Family of Companies (06/04/25)
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