Manufacturing Engineering Position
We seek an experienced production engineering specialist to support our manufacturing operations in Galway.
About the Role
* Collaborate with process owners to identify and address compliance gaps.
* Assist with manufacturing process validation activities (IQ/OQ/PQ).
* Update quality system documentation and technical files for audit readiness.
* Drive resolution of CAPAs and NCRs through effective corrective actions.
* Provide clear technical writing for quality and manufacturing procedures.
Key Requirements:
* Bachelor's degree in Engineering or a Quality-related discipline.
* 25 years of experience in medical device manufacturing, quality, or remediation projects.
* Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
* Proven technical writing and documentation skills.
* Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
* Excellent problem-solving skills with the ability to develop compliant solutions.