• Scientist I, Pharmaceutical Analysts

    Cardinal Health (Mansfield, MA)
    …(LIMS), such as LabWare. + Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing. + ... or testing environment, preferred. + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory… more
    Cardinal Health (12/17/25)
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  • Manager, Production Equipment Services

    J&J Family of Companies (Danvers, MA)
    …calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Equipment Selection & Acquisition** + Partner ... PM plans, calibration certificates, equipment histories, change controls, and validation artifacts as needed. **Performance Reporting** + Ensure calibration… more
    J&J Family of Companies (12/06/25)
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  • Clinical Outcome Assessment (COA) Lead

    Sanofi Group (Cambridge, MA)
    …assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers ... research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination + Manage the qualitative and quantitative… more
    Sanofi Group (01/07/26)
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  • Senior Systems Test Engineer

    Hologic (Marlborough, MA)
    …or subsystems. + Own the design and development of test and validation methods for test equipment. Write plans, procedures, and protocols for software/hardware ... testing activities. (verification and/or validation ). Execute verification and/or validation protocols. +...process improvements. + Medical imaging or experience in an FDA -regulated environment is beneficial. + Ability to meet project… more
    Hologic (12/18/25)
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  • Senior Quality Lead-Quality Compliance

    Philips (Cambridge, MA)
    …Matter Expert (SME) for non-conformance, driving non-conformance reduction and process validation maturity in close cooperation with the Quality leads in Philips ... /businesses. + Have an impact on processes such as the introduction/ validation of new/changed manufacturing processes and their associated Quality systems, trend… more
    Philips (12/17/25)
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  • Quality Calibration Technician II

    Integra LifeSciences (Braintree, MA)
    …+ Ensure calibration records are complete, traceable, and compliant with FDA , ISO, and internal standards. + Troubleshoot and resolve calibration-related issues ... systems and compliance requirements. + Support installation, qualification, and validation of new instruments and equipment, ensuring adherence to...preferred. + Strong knowledge of ISO 17025, ISO 13485, FDA 21 CFR Part 11, and GMP compliance. +… more
    Integra LifeSciences (01/07/26)
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  • Senior Clinical Outcomes Assessment (COA) Lead

    Sanofi Group (Cambridge, MA)
    …assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers ... asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead...COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation… more
    Sanofi Group (01/07/26)
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  • Senior Product Quality Engineer

    Hologic (Marlborough, MA)
    …engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU ... risk-based decision-making processes. + Preferred: Familiarity with test method validation , statistical methods, and standards related to reliability, electrical… more
    Hologic (12/12/25)
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  • Sr Systems Engineer, Abiomed

    J&J Family of Companies (Danvers, MA)
    …analyses, and regulatory requirements. + Author, review, and approve verification and validation (V&V) test plans, protocols, procedures, and reports. + Plan and ... and standards (for example, IEC 60601-1 _IEC_ 60601-1 and applicable FDA guidance). + Experience with communication interfaces and embedded systems (UART,… more
    J&J Family of Companies (12/03/25)
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  • Engineer: Sr. Electrical Design Engineer

    Nanobiosym, Inc. (Cambridge, MA)
    …lifecycle: Specification, architecture, circuit design, simulation, schematic capture, prototyping, validation , and release to manufacturing. + Lead PCB design and ... hardware and driver requirements. + Design and build test fixtures for hardware validation and functional testing. + Support regulatory and quality processes with a… more
    Nanobiosym, Inc. (11/18/25)
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