• Sr. Quality Engineer

    Abbott (Temecula, CA)
    …design change projects + Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation ... + Lead design test and inspection method development, and lead method validation activities + Ensure DHF content completion, integrity, and regulatory & standards… more
    Abbott (05/15/25)
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  • Senior Software Quality Engineer

    J&J Family of Companies (Santa Clara, CA)
    …organizational, problem solving, and analytical skills + Working knowledge of IEC 62304, FDA 's General Principles of Software validation , ISO 13485, ISO 14971, ... software architecture and design, product security, software verification and validation ) to ensure that they comply with applicable procedures standards… more
    J&J Family of Companies (06/17/25)
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  • Associate Director, GxP Systems

    Vera Therapeutics (Brisbane, CA)
    …configuration, testing, and deployment. * Partner with QA to develop and maintain Computer System Validation (CSV) documentation per GAMP5 and 21 CFR Part ... Commercialization Systems and will be responsible for leading the implementation, validation , and support of GxP-regulated systems to enable Quality, Regulatory,… more
    Vera Therapeutics (06/25/25)
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  • Quality Engineer

    Bio-Techne (San Marcos, CA)
    …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
    Bio-Techne (06/13/25)
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  • Senior Specialist, Conformance

    Bayer (Berkeley, CA)
    …including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits; + Ability to ... and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation , and Quality Systems (Deviation and CAPA management, Change Control,… more
    Bayer (06/05/25)
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  • Mechanical Development Quality Engineer I

    Abbott (Sylmar, CA)
    …design change projects. + Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis ... + Support design test and inspection method development, and lead method validation activities. + Ensure DHF content completion, integrity, and regulatory &… more
    Abbott (05/20/25)
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  • Senior Embedded Software Engineer

    Abbott (Alameda, CA)
    …**What you'll work on** + Lead software development, verification, and validation ; responsible for on-time delivery of high-quality embedded software biowearable ... approved design control procedures for software development in accordance with FDA guidelines. + Lead software development projects, providing mentoring and… more
    Abbott (06/07/25)
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  • Staff Systems Verification Engineer

    Abbott (Pleasanton, CA)
    …to work area. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and ... task assignments. **Required Qualifications** + Bachelor's Degree in Engineering ( Computer , Electrical, Software, or Biomedical), Computer Science, or related… more
    Abbott (06/02/25)
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  • Product Security Engineer (Hybrid; NYC, Loveland…

    Antech Diagnostics (Fountain Valley, CA)
    …on emerging security threats, vulnerabilities and mitigation techniques. **Product Security Validation :** + Organize and support the product security review process ... delivery and required level of quality in all aspects of the validation process. + Provide Standardized product security documentation. + Collaborate with other… more
    Antech Diagnostics (06/26/25)
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  • Doc Control Specialist

    Actalent (Irvine, CA)
    …regulatory requirements, including but not limited to Site, Division, Corporate, FDA , ISO, MDD, and individual country requirements. This role involves engaging ... product development lifecycle, including risk management and design/process verification and validation . + Knowledge of Advanced Quality tools such as FMEA, GD&T,… more
    Actalent (07/03/25)
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