• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • [email protected]
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     [email protected]
  • Quality Engineer – Co. Cork

    Role Summary:


    • A fantastic opportunity has arisen for a Quality Engineer to join our client’s facility in Co. Cork.
    • The successful candidate will provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
    • The Quality Engineer will ensure Regulatory compliance in the area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI).


    Core Duties and Responsibilities:


    • Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
    • Ensure compliance of QMS procedures within the Business Unit.
    • Lead Problem Solving meetings using the following: 4D, Six Sigma, etc.
    • Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
    • Drive and implement plant wide quality system improvements.
    • Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
    • Provide functional expertise to other support function on quality related issues.
    • Manage NCR Process.
    • Interface with Suppliers for new processes, quality Issues and Process Improvements.
    • Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
    • Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
    • Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, sCAPA, Validations, Process Changes, NCR, Quality Alert, Quality Challenge.
    • Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.
    • Support site during External Audits. (i.e. FDA, IMB and BSI).
    • Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
    • Responsible for input to Quality Metrics.
    • Evaluation of Customer Complaints (PER Investigation) as required.


    Minimum Qualifications and Experience:


    • Degree in Engineering, Science or equivalent is required.
    • 0 – 2 years experience in a QA role.
    • Good level of technical and analytical skills.
    • Problem Solving Skills and ability to handle multiple tasks in a fast paced environment.
    • Capable of working as part of a multi discipline team.
    • The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
    • High level of PC skills required.
    • Excellent Communicator


    To Apply: Quote – PE23094


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    [email protected]

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.