Manufacturing Engineer
3 weeks ago
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:
or
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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