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Quality Engineer

    Quality Engineer - County Roscommon, Ireland - Cpl

    Cpl
    Cpl County Roscommon, Ireland

    Found in: beBee S2 IE - 6 days ago

    CPL background
    Full time
    Description

    Quality Engineer

    My client, a global partner for the design, development and manufacture of medical devices, is looking to hire a Quality Engineer on a permanent basis.

    This is a permanent onsite role, based in Carrick-on-Shannon,

    Responsibilities

    • Integration & Maintenance of the Quality Management System, in accordance with ISO Standards 13485, MDD 93/42/EEC & MDR 2017/745.
    • Ensure that products manufactured meet customer requirements
    • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
    • Review and Release of batch paperwork for Product release
    • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO
    • Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
    • Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme
    • Participation in routine Failure Investigation.
    • Maintenance of plant Trending & Continuous process improvement programmes
    • Participation in the Plant Corrective Action Programme
    • Participation in the Internal Quality Audit Programme
    • Co-ordination & maintenance of the Calibration Programme
    • Co-ordination & maintenance of the Validation Programme

    Requirements

    • Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum bachelor's degree in a Science / Engineering / Quality related discipline
    • 2+ years' experience as Quality or Validation Engineer in Medical Device/Pharmaceutical Environment
    • Knowledge of Minitab.

    For more information, please contact

    #LI-DC6

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