• Manager, Automation Engineering- Onsite

    AbbVie (Worcester, MA)
    …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more
    AbbVie (09/15/25)
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  • Senior Manager of Statistics- CMC

    Takeda Pharmaceuticals (Cambridge, MA)
    …role will also support clinical/biomarker assay development and validation . For more information on CMC, click here ... and leadership for Takeda clinical and biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality… more
    Takeda Pharmaceuticals (09/03/25)
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  • Microbiology Technician II

    Integra LifeSciences (Braintree, MA)
    …quality control microbiological laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... and checklists. + Assist as needed in test method validation , investigation studies or other product development studies. +...studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    Integra LifeSciences (11/05/25)
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  • Quality Control Technician II, Analytical

    Integra LifeSciences (Braintree, MA)
    …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    Integra LifeSciences (10/25/25)
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  • Lead Software Design Assurance Engineer

    Hologic (Marlborough, MA)
    …lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory ... innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. +… more
    Hologic (10/30/25)
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  • Systems Verification Engineer II

    Olympus Corporation of the Americas (Westborough, MA)
    …supporting the design, development, documentation and execution of system verification & validation plans, protocols and reports to ensure that Olympus products meet ... compliance to applicable regulatory and corporate domestic and international standards/requirements (eg, FDA QSR, ISO 13845, EUMDR) as they apply to verification and… more
    Olympus Corporation of the Americas (11/12/25)
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  • 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 (10/30/25)
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  • Group Engineering Manager, Algorithms & Software

    Globus Medical, Inc. (Methuen, MA)
    …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance** + Ensure adherence to IEC 62304 ... cybersecurity standards. + Maintain documentation for design controls, verification, and validation activities. + **Innovation & Research** + Stay current with… more
    Globus Medical, Inc. (11/06/25)
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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 II

    Catalent Pharma Solutions (Chelsea, MA)
    …manufacturing. The candidate provides support in automation engineering, design, and validation . The Automation Engineer II contributes to the design and ... Part11 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 (10/16/25)
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