• Senior Supplier Engineer

    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 (12/13/25)
    - Related Jobs

  • Staff Device Engineer

    Takeda Pharmaceuticals (Lexington, MA)
    …specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive ... key technical role is responsible for change controls, manufacturing process validation , device product complaints, regular review of DHF, and post-market… more
    Takeda Pharmaceuticals (12/05/25)
    - Related Jobs

  • Manager, Nonclinical Statistics

    Takeda Pharmaceuticals (Cambridge, MA)
    …to preclinical and clinical biomarker assay development and validation . For more information on CMC, click here ... leadership for Takeda preclinical and clinical biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global… more
    Takeda Pharmaceuticals (12/03/25)
    - Related Jobs

  • Supplier Quality Engineering Co-Op

    ZOLL Medical Corporation (Chelmsford, MA)
    …departments with the day-to-day issues relating to supplier certification, validation and quality. Maintain quality systems associated with supplier management. ... with reviews of supplier performance data, in evaluation and validation of supplier change requests, generates brokerage component MCOs...with standards and regulations such as ISO13485, IS09001, and FDA 21 CFR Part 820. + Must be currently… more
    ZOLL Medical Corporation (12/02/25)
    - Related Jobs

  • Director, Design Assurance

    Hologic (Marlborough, MA)
    …ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant. + Address technical and project-based ... controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams. **Qualifications:** +… more
    Hologic (11/19/25)
    - Related Jobs

  • QC Scientist I Raw Materials

    Astellas Pharma (Westborough, MA)
    …+ Design and perform testing in support of method transfer/ validation /qualification/verification + Review/authorize data and perform analysis and interpretation of ... and trends + Design and/or participate in method development; equipment qualification/ validation studies; deviation and OOS investigations + Perform QC lab support… more
    Astellas Pharma (11/07/25)
    - Related Jobs

  • Lead Design Assurance Engineer

    Hologic (Marlborough, MA)
    …standards for safety, effectiveness, and innovation. **Knowledge:** + Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 ... + Thorough knowledge of design control processes, verification and validation planning, and requirements traceability. + Familiarity with Good Laboratory… more
    Hologic (10/30/25)
    - Related Jobs

  • 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)
    - Related Jobs

  • 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)
    - Related Jobs

  • Manager, Design Assurance

    Hologic (Marlborough, MA)
    …Lifecycle Management System is beneficial. + Advanced knowledge of FDA -Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO ... Advanced knowledge of Risk Management + Advance knowledge of verification and validation requirements for a regulated product + Advanced knowledge or requirements… more
    Hologic (01/13/26)
    - Related Jobs