Medical Devices JobsQuality Engineer

  • 50942
  • Permanent
  • Offaly, Westmeath

Collins McNicholas

Quality Engineer


  • Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
  • Conduct detailed root cause analysis and define corrective and preventive actions for NCR.
  • Management of the calibration of QA, Product and Engineering equipment
  • Work with engineering teams to identify trends in failures, support root cause analysis and implementation of corrective actions
  • Conduct Internal audits.
  • Develop Inspection plans for Incoming inspections, in process and Final QA inspection for products manufactured
  • Detailed Review and approval of Risk Managements files
  • Review and Approval of Change Orders associated with components and manufacturing process,
  • Provide Operational QA Support for products and process.
  • Lead / team member of CAPA as required
  • Oversight and management of the MRB process
  • Lead KATA investigations towards root cause


  • Education:

Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical) .

  • Experience:
    • Three to five years of experience in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
    • Accredited Lead/Biomedical Auditor certification strongly preferred.
    • Knowledge of IEC 60601 electrical safety standards and RoHS and WEEE regulations strongly preferred.
    • Lean/Six Sigma certification strongly preferred.
    • Strong project management skills required.
    • Demonstrated knowledge of statistical sampling and analysis.
    • Demonstrated excellent organizational, writing and verbal communication skills
    • Proficient with the MS Office Suite, including Microsoft Visio and Project.
    • Experience working in Oracle, Agile and TrackWise systems preferred
    • Demonstrated knowledge of FDA regulations, applicable medical device/quality system ISO standards, CMDR, MDD and other national and international regulations and standards.
    • Must be able to work independently with minimal supervision.

          For more information or a confidential discussion on the role, please contact David Lennon

          Tel: 0906478104


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