• Vice President of AI and Software…

    Vitalief (New Brunswick, NJ)
    …care needs. + Manage risk across technology projects and ensure all AI and software solutions adhere to regulatory requirements (eg, FDA , EMA), industry best ... vision, driving advancements and innovation at the intersection of advanced AI, software development, and clinical research. This role requires a deep understanding… more
    Vitalief (03/16/25)
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  • Manager, Product Quality Complaints

    Otsuka America Pharmaceutical Inc. (Princeton, NJ)
    …+ Participate in internal audits and external audits conducted by the FDA and other regulatory agency representatives. Support Quality Management Systems ... Biologics products and/or medical device industry + Experience in analyzing product quality complaints and determining reportability to the FDA and other… more
    Otsuka America Pharmaceutical Inc. (03/27/25)
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  • Sr. Quality Engineer / Quality…

    Integra LifeSciences (Plainsboro, NJ)
    …and set new standards of care. The **Sr. Q** **uality Engineer / Quality Operations (Validations, Risk Management & Statistics)** will provide Plant Quality ... into the Manufacturing Site. Participate in problem solving teams. Facilitate from a Quality Engineering & Quality Systems and Plant perspective the launching of… more
    Integra LifeSciences (04/09/25)
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  • Global Quality Auditor - Technology Audit…

    Sanofi Group (Morristown, NJ)
    **Job title** : Global Quality Auditor - Technology Audit and Inspection **Location:** Morristown, NJ or Framingham, MA **About the Job** We deliver 4.3 billion ... Expertise. Are you ready to shape the future of Quality Audits? As _Global Quality Auditor -...computerized systems, in vitro diagnostics (IVDs), radio pharma products, software as medical device (SaMDs) meet regulatory requirements and… more
    Sanofi Group (05/16/25)
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  • SAP Quality Management Specialist

    Terumo Medical Corporation (Somerset, NJ)
    …(KSA)** + Medical Device/Serialized product experience is required + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills ... SAP Quality Management Specialist Date: Apr 30, 2025 Req...develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of… more
    Terumo Medical Corporation (05/05/25)
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  • Executive Director of R&D Global Quality

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    …Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a ... global team focused on R&D Quality . This global role includes direct reports in the...Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment +… more
    Otsuka America Pharmaceutical Inc. (04/30/25)
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  • Inventory Quality and Control Manager…

    CVS Health (Jersey City, NJ)
    …with heart, each and every day. **Job Purpose & Summary:** The Inventory, Quality , and Control Manager is responsible for overseeing all aspects of inventory ... management (core production, NPI/Damages, cycle counts, slotting) and quality assurance (security, investigations, root cause analysis, inventory variance… more
    CVS Health (04/23/25)
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  • Senior Quality Engineer

    Spectrum Plastics Master (Wall, NJ)
    …(NOAs), and Nonconforming Material Reports (NCRs) related to sustaining processes. * Quality Representative for process and software validations (may require ... SUMMARY: Senior Quality Engineer is responsible for supporting validations, qualifications,...and knowledge. * Basic knowledge of ISO 13485:2016 and FDA QSR. * Strong root-cause investigator and problem solver… more
    Spectrum Plastics Master (03/15/25)
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  • Quality Assurance Engineer II

    Integra LifeSciences (Plainsboro, NJ)
    …pathways to advance patient outcomes and set new standards of care. The ** Quality Assurance Engineer II** will provide Quality compliance support on all ... aspects of the Plainsboro, NJ CMC Quality System. The Quality Assurance Engineer II...following regulations and guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485, Medical Device Directive… more
    Integra LifeSciences (03/11/25)
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  • Integration Specialist - informatica/AWS

    Sanofi Group (Bridgewater, NJ)
    …and mitigation strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between various systems ... processes, and meet the business needs with the agreed quality of service. + Responsible throughout the entire project...while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work closely with QA and… more
    Sanofi Group (05/01/25)
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