• Business Analyst Manager, SSDM

    Sanofi Group (Morristown, NJ)
    … computer science) or previous experience in Pharmacovigilance Safety Database/ validation experience working in a highly regulated environment + Additional ... into the appropriate technical language to ensure that configuration, operations, validation , and/or analytic reporting deliverables meet business needs. This role… more
    Sanofi Group (07/25/25)
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  • CQV Engineer Mid-Level

    Sokol Materials & Services (Skillman, NJ)
    …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills....Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up… more
    Sokol Materials & Services (07/24/25)
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  • Embedded Software Engineer

    Abbott (Alameda, CA)
    …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... **The Opportunity** The Embedded Software Engineer oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA… more
    Abbott (06/26/25)
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  • Manager, Quality Assurance & Regulatory

    Tecomet (Woburn, MA)
    …improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet principles ... Technical Files, and Design Dossiers and Change Notices. + Serve as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). +… more
    Tecomet (07/31/25)
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  • CQV Engineer Senior Level

    Sokol Materials & Services (Skillman, NJ)
    …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more
    Sokol Materials & Services (06/24/25)
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  • Software Quality Engineer II

    Abbott (Sylmar, CA)
    …R&D in the completion of system/software requirements and other verification and validation processes related to embedded software products. + Participate in reviews ... provide useful feedback. + Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time… more
    Abbott (07/03/25)
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  • CMSU Research Quality Assurance Coordinator III

    University of Rochester (Rochester, NY)
    …ClinPro LBL (TM) computerized clinical label generation system. + Provide input into validation protocols and implement computer system validation of ... Good Manufacturing Practices (cGMP) as defined in 21 CFR FDA regulations and apply those to the procurement, handling,...acting as second QA check of the execution of validation scripts, and manages metrology activities; calibration of in-process… more
    University of Rochester (08/07/25)
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  • Principal Engineer - Systems

    Lilly (Branchburg, NJ)
    …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. ... local and corporate policies). + Provide IDS technical and/or validation direction related to computer system Change...regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg Privacy, OSHA, etc.)… more
    Lilly (08/02/25)
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  • Principal Electrical Engineer

    Medtronic (Minneapolis, MN)
    …rates. You will have primary focus and responsibility for the validation of design verification test methods for complex electro-mechanical medical devices. ... for leading the team that is responsible for the validation of Design Verification Test Methods for a new...Medical Device Industry experience. + Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO… more
    Medtronic (08/08/25)
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  • Quality Engineer - Casa Grande Nutrition Plant…

    Abbott (Casa Grande, AZ)
    …from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected ... lives of millions worldwide. **What You'll Work On** + Review RCEs, Validation documents, Preventative Maintenance & Calibration records to identify impact to… more
    Abbott (07/18/25)
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