• Quality Assurance Engineer

    Nanobiosym, Inc. (Cambridge, MA)
    …the process and product monitoring, including the creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting ... in statistical analysis and statistical process control + Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment PERSONAL QUALITIES + You… more
    Nanobiosym, Inc. (07/24/25)
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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 ... but not limited to, ECRs, DCRs, ECOs, DCOs, and MCOs. deviations, validation records, batch records, and notebooks. + Responsible for processing change orders… more
    Integra LifeSciences (07/16/25)
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  • Senior Manager, Programming

    Takeda Pharmaceuticals (Boston, MA)
    …SDTM and ADaM datasets as per CDISC IG (Implementation guide) and FDA TCG (Technical conformance Guide); contribute to process improvement initiatives for creating ... database and planned analysis are collected; review Data Transfer specifications, Data Validation Plans, and various other study documents and ensure they meet the… more
    Takeda Pharmaceuticals (07/05/25)
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  • Manufacturing Engineer

    Nanobiosym, Inc. (Cambridge, MA)
    …the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with details of ... process control + Electromechanical experience is required + Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Good communication… more
    Nanobiosym, Inc. (07/01/25)
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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 ... of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation… more
    Fresenius Medical Center (06/14/25)
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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 (06/13/25)
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  • Engineer: Injection Molding Engineer

    Nanobiosym, Inc. (Cambridge, MA)
    …products and processing thru numerous manufacturing steps. + Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. + Provide ... statistical process control + Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Strong written and… more
    Nanobiosym, Inc. (06/05/25)
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  • Lead Project Engineer

    Fujifilm (Boston, MA)
    …(PE) oversees all technical aspects of Synapse product implementation, from solution validation phases through product go-live.. Lead PE's must have expert level ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
    Fujifilm (07/24/25)
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  • Process Development Principal Scientist

    Amgen (Cambridge, MA)
    …+ Experience in method development, qualification, transfer, troubleshooting, method validation , and complex investigations. + Familiarity with and understanding of ... and International Conference on Harmonization (ICH) / Food & Drug Administration ( FDA ) mentorship documents related to analytical method transfer and validation .… more
    Amgen (07/24/25)
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  • Supplier Engineer II

    J&J Family of Companies (Danvers, MA)
    …on Abiomed delivery forecasting + Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier + Partner with internal ... ERP systems (SAP preferred) + Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports required. Experience designing and… more
    J&J Family of Companies (07/23/25)
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