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Quality Engineer- Medical Devices

  • Location: County Westmeath
  • Job Type:Permanent

Quality Engineer| Westmeath| Permanent

Reporting to the Senior Quality Engineer, the Quality Engineer will support the development of a new manufacturing process at the site and enhance the process and related quality system over time. Customer onboarding and interaction is a significant element of the position.

Quality Engineer responsibilities:

  • Lead quality improvement programmes using recognised problem-solving and project management techniques
  • Interface on an ongoing basis with customers to ensure requirements concerns/complaints are communicated and corrective and preventive actions are closed in a timely and effective manner. Customer onboarding process is a key element of the position. 
  • Management of customer documents into the Quality system i.e., Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel. 
  • Drafting and approving of quality documentation to meet Customer requirements i.e., Quality Specification Sheets (QSS), CAPA’s, Defect Library etc.
  • Trending and track of quality data to support quality improvements across the business
  • Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented. 
  • Adherence to incoming control requirements and supporting the SCAR process when required. 
  • Participate in the review of validation protocols and reports to ensure quality compliance.
  • Executing internal process and system audits.
  • Manage quality projects in support of continuous improvement e.g., Lean Projects.
  • Co-ordinate activities associated with change management and customer interaction. 
  • Ensuring the timely and effective closure of day-to-day quality issues.
  • Batch paperwork review and final decision to release product for shipment
  • Coach and drive a culture of compliance and continuous improvement.
  • Compliance to all site Environmental, Health and Safety requirements, training and regulations. 

Quality Engineer Requirements:

  • Third level qualification in Engineering / Quality / Science.
  • 2+ years’ work experience in a Medical Device manufacturing environment is essential.
  • A working knowledge of quality systems such as ISO 13485 is essential.
  • An in-depth knowledge of validations and change control management in a Medical Device environment.
  • Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.


For a confidential discussion, please contact Tina Cornally.