• Quality Technician 1

    Teleflex (Mansfield, MA)
    …nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification ... * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests *...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more
    Teleflex (09/16/25)
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  • Sr. Software Quality Engineer

    Fresenius Medical Center (Lawrence, MA)
    …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... individuals with disabilities to perform the essential functions. . Extended computer -based work in an office environment. **EDUCATION** . Bachelor's Degree required… more
    Fresenius Medical Center (09/13/25)
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  • Automation Engineer III

    Catalent Pharma Solutions (Chelsea, MA)
    …The candidate takes part in ownership of automation engineering, design, and validation . The Automation Engineer III contributes to the design and implementation of ... assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control… more
    Catalent Pharma Solutions (09/27/25)
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  • Lead Microbiology Technician

    Integra LifeSciences (Braintree, MA)
    …archived materials and solutions. + Assist as needed in test method validation , implementation, and execution. + Provides database support, generate reports and ... analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent… more
    Integra LifeSciences (08/08/25)
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  • Document Control Specialist

    Integra LifeSciences (Braintree, MA)
    …implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains ... limited to, ECRs, DCRs, ECOs, DCOs, and MCOs. deviations, validation records, batch records, and notebooks. + Responsible for...such as batch records and validations + Have advanced computer skills to increase department productivity, as well as… more
    Integra LifeSciences (07/16/25)
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  • Specialist, Lead Manufacturing Associate, Cell…

    Bristol Myers Squibb (Devens, MA)
    …their work. + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
    Bristol Myers Squibb (09/30/25)
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  • Manufacturing Associate II, Cell Therapy in

    Bristol Myers Squibb (Devens, MA)
    …their work + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
    Bristol Myers Squibb (08/12/25)
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  • Packaging Engineer II

    Medtronic (Billerica, MA)
    …pharmaceutical, or other regulated industries. + Knowledge of **ISO, ASTM, and FDA regulations** related to packaging validation and compliance. + Familiarity ... to be independently mobile. The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your manager or local HR to… more
    Medtronic (09/30/25)
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  • Senior Quality Systems Manager, Design Quality…

    Medtronic (Boston, MA)
    …in compliance with medical device standards. + Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing ... and interpersonal skills + Demonstrated working knowledge of process validation , statistical methods, risk management **Physical Job Requirements** The above… more
    Medtronic (09/25/25)
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  • Software Design Quality Engineer Co-op

    J&J Family of Companies (Danvers, MA)
    …in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering, Computer /Software Engineering or a related field. + ​Completion of ... or software development and test engineering related experiences. + ​Knowledge of FDA or regulatory guidance + ​Medical related experience (previous co-op at medical… more
    J&J Family of Companies (09/18/25)
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