Senior Quality Engineer – Limerick

Working as part of the Design Assurance team you will be required to support the product throughout it’s entire life cycle from inception to launch.


  • Design Assurance Quality Engineer on project core teams for design change projects.
  • Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction.
  • Generate test protocols based on specification requirements.
  • Perform statistical analysis of results.
  • Review quality objectives and ensure they are sufficiently defined in specifications, procedures, and testing.
  • Guides the successful completion of major programs and may function in a project leadership role.
  • Provides management with review opportunities at key points.
  • Ensures quality conduct of projects, including design, data summary and others.
  • Implements and communicates the strategic and technical direction for the product/project team.
  • Identifies any issues that may delay product or project and recommends appropriate action to be taken.


  • BSc. in Engineering required or related discipline.
  • 5-7 years of medical device quality engineering experience.
  • Expertise in design assurance including design controls.
  • Embedded software validation experience advantageous.
  • Capital Equipment validation advantageous.
  • Experience with Risk Management advantageous.
  • Ability to act as Change Agent.
  • Experience working with cross-functional teams.
  • Previous experience working in a regulated FDA industry.
  • Must be authorised to work in Ireland.

Please contact Emer Smith to discuss in confidence


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