• Sr. SW Product Owner

    Medtronic (Boston, MA)
    …design, code implementation, unit test, and software and system verification and validation . You will also participate in SAFe/Agile activities including but not ... with medical devices and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and IEC 62304. Experience performing risk… more
    Medtronic (07/17/25)
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  • Quality Control Technician

    North Coast Seafoods (Boston, MA)
    …and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle + 1+ years, experience in food manufacturing; seafood or ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit +… more
    North Coast Seafoods (07/17/25)
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  • Quality Engineer II (Manufacturing)

    Teleflex (Chelmsford, MA)
    …Engineering with new product development with quality planning, risk evaluation, and validation . * Perform any additional QA tasks, as assigned by QA Manager. ... Skills / Other Requirements** * Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements. * Computer skills, including proficiency with Microsoft Word, Excel,… more
    Teleflex (07/16/25)
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  • Lab Recruiter

    Aston Carter (Boston, MA)
    …Life Sciences, or a related field. + Strong understanding of GMP, FDA regulations, and other compliance standards. + Excellent communication, interpersonal, and ... Experience recruiting for roles such as QC Analysts, QA Specialists, Validation Engineers. + Familiarity with pharmaceutical manufacturing processes and terminology.… more
    Aston Carter (07/15/25)
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  • Packaging Operation Associate, Cell Therapy Supply…

    Bristol Myers Squibb (Devens, MA)
    …compliance + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... and verbally communicate in English + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. **Basic… more
    Bristol Myers Squibb (07/13/25)
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  • Manager, Quality Assurance (QA), Global QMS

    Rhythm Pharmaceuticals (Boston, MA)
    …Veeva QDocs, ensuring documents meet procedural and regulatory requirements. + Participate in validation efforts for new or updated GxP IT systems through review of ... systems, and learning management systems. + Strong working knowledge of relevant FDA , EU, ICH GMP regulations and guidelines with proficiency in interpreting and… more
    Rhythm Pharmaceuticals (07/12/25)
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  • Associate Director, Product Quality

    AbbVie (Waltham, MA)
    …and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA , EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections. + ... assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required. + A wide range of activities are… more
    AbbVie (07/11/25)
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  • Quality Engineer 2, Design Assurance PMS

    Teleflex (Chelmsford, MA)
    …support activities in product and process design such as design verification, design validation , design reviews, design transfer, and all other aspects of a design ... * Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab or other statistical softwares. *… more
    Teleflex (07/09/25)
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  • Senior Clinical Research Director, I&I

    Sanofi Group (Cambridge, MA)
    …development activities (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute to the clinical ... part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health… more
    Sanofi Group (07/06/25)
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  • Clinical Lead, I&I

    Sanofi Group (Cambridge, MA)
    …eg protocol development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment + Support and input preparation ... the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions… more
    Sanofi Group (07/04/25)
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