• Quality Systems Manager

    PCI Pharma Services (Philadelphia, PA)
    … quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of cGMP and other applicable ... requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations… more
    PCI Pharma Services (06/26/25)
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  • Assoc. Dir., Engineering , Combination Products…

    Merck (West Point, PA)
    …sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate will ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device … more
    Merck (08/12/25)
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  • Quality Engineer

    Envista Holdings Corporation (Quakertown, PA)
    …regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster strong ... problem-solving and cooperation. + Experience and working knowledge of electrical medical device manufacturing (preferred). + Experience with SAP is… more
    Envista Holdings Corporation (08/16/25)
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  • Director, Combination Product Commercialization

    Merck (West Point, PA)
    …advanced degree (Master's or PhD) preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a ... + Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and… more
    Merck (08/08/25)
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  • Associate Director, External Manufacturing…

    Merck (West Point, PA)
    …and Skills: . **Manufacturing** - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset. As the primary point of contact...development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU … more
    Merck (08/18/25)
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  • Digital Quality Systems Manager

    ThermoFisher Scientific (Pittsburgh, PA)
    …13485, IVDR, cGMP's, FDA Guidelines, USP, and GxP. + Detailed knowledge of medical device manufacturing processes and experience with risk management regulations ... to develop, modify, improve, and implement IT systems for the Quality and Regulatory Organization. + Develop policies and procedures supporting IT Systems used… more
    ThermoFisher Scientific (08/23/25)
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  • Medical Safety Specialist II - Bilingual…

    Olympus Corporation of the Americas (Center Valley, PA)
    …control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device preferred to Pharma) OR ... Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research &...Progressive leadership experience in the health care setting. + Medical Safety ( Medical Device preferred… more
    Olympus Corporation of the Americas (07/24/25)
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  • Distinguished Scientist, Autoinjector Platform

    Merck (West Point, PA)
    …and support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and ... all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory , and manufacturing teams across...a minimum of 20 years of hands-on experience in medical device engineering, with a focus on… more
    Merck (08/28/25)
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  • Principal, Quality Assurance, GMP

    West Pharmaceutical Services (Exton, PA)
    …of quality -related experience with preferred experience in pharmaceutical and/or medical device industry + Expertise of cGMP requirements, ISO standards ... Principal, Quality Assurance, GMP Requisition ID: 70962 Date: Aug...laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer… more
    West Pharmaceutical Services (08/24/25)
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  • Director - Packaging Technology

    Sanofi Group (Swiftwater, PA)
    …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... market auto-injectors, pens, safety syringes, as well as connected medical device technologies, and we are gearing...equipment, printing, and vision control systems. + Knowledge of device and packaging regulations, quality systems, design… more
    Sanofi Group (08/08/25)
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