Manufacturing Engineer

4 weeks ago


Galway, Galway, Ireland CREGG Full time

Our client, a global leader in medical device industry based in Galway, is looking for skilled Quality Engineers / Manufacturing Engineers.

This is an excellent opportunity to work onsite and partner closely with manufacturing and quality teams to strengthen compliance and support process validation projects.

For more info: contact Mark:

0861901843 or markhalligan@cregg.ie

Responsibilities

  • Work alongside manufacturing owners to identify gaps and implement corrective actions to achieve compliance.
  • Contribute to equipment and process validation activities (IQ/OQ/PQ).
  • Revise and maintain quality system records and technical documentation to ensure audit readiness.
  • Lead and support the closure of CAPAs and NCRs with robust corrective actions.
  • Develop clear, accurate technical documentation and SOPs for quality and manufacturing processes.
  • Collaborate with cross-functional teams, including Manufacturing, Quality, and Regulatory, to deliver sustainable solutions.

Skills & Experience Required

  • Degree in Engineering, Quality, or a related discipline.
  • 2–5 years of experience in medical device manufacturing, quality engineering, or remediation work.
  • Strong background in process validation (IQ/OQ/PQ) and CAPA/NCR resolution.
  • Excellent technical writing and documentation abilities.
  • Solid understanding of 21 CFR Part 820 and ISO 13485 requirements.
  • Strong problem-solving mindset, with the ability to drive issues to fully compliant solutions.
  • Willingness to work onsite in Galway.
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