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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