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Gaillimh

    Senior Design Assurance Manager - County Galway, Ireland - Cpl

    Cpl
    Cpl County Galway, Ireland

    Found in: beBee S2 IE - 6 days ago

    CPL background
    Full time
    Description

    My client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis.

    Responsibilities

    · Develop & manage execution of the Design Controls process.

    · Provide Design Assurance oversight within the NPI area.

    · Manage resources to support product launches.

    · Coordinate regular design reviews.

    · Ensure product/process/label and test method designs and documentation comply with regulatory requirements.

    · Monitor post-market surveillance trends.

    · Collaborate with R&D and Design Quality teams to ensure successful new product launches and design transfer process.

    · Represent design quality with external regulatory authorities and respond to queries.

    · Collaborate with Regulatory Affairs & R&D to establish appropriate filing.

    · Collaborate with R&D on Product Test Methods.

    · Work with R&D on product scale-up and transfer to commercial manufacture.

    · Develop design assurance processes, systems, and staff.

    Requirements

    · Degree in Engineering/Science/ Life Sciences.

    · 5 years minimum experience in QA/R&d or other technical leadership role in a regulated environment

    · Extensive knowledge of Medical Devices and experience in a fast-moving R&D environment.

    · Track record of delivering successful NPI programs

    · Track record of delivering successful CI programs.

    · Experience managing in an environment with changing priorities

    · Experience managing a design assurance team essential.

    If interested please send your CV to

    #LI-EL2

    #CplEmerLong

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