• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • Quality Engineer – Wexford

    Role Purpose:

    • Participates in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non conformances so that issues are resolved to close out with no recurrences.

     

    Duties:

    • Ensures compliance to quality system requirements as defined by procedures, FDA QSR, ISO 13485 and applicable international and national standards (e.g. EN, ASTM) through active participation in the divisional and cross divisional product and process development system
    • Provides Quality Engineering representation on cross-functional product development teams
    • Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance
    • Leads cross-functional teams to develop risk assessments and risk controls
    • Supports development of appropriate product/component specifications and supports development and validation of inspection/test method
    • Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups
    • Applies risk management, change control, and validation principles throughout the product lifecycle
    • Supports the divisional corrective / preventive action program by applying root cause analysis and problem solving techniques and by implementing corrective/preventive actions

     

    Qualifications:

    • Min Engineering or Science degree required
    • Experience in medical device industry or similar industrial environment (areas see above) with good working knowledge of regulatory requirements and Quality Systems techniques
    • Experience in risk-based decision making and problem-solving

     

    To Apply

    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
    recruitment@prochem.ie

    Click here to submit your CV