Manufacturing Engineer - Galway - (Hybrid role) - Medical Device
Our client, a global leader in medical device industry based in Galway, is looking for skilled Manufacturing Engineers to work in this Manufacturing Projects role.
This is an excellent opportunity to work and partner closely with manufacturing and quality teams to strengthen compliance and support process validation and NPI, process improvement projects.
For more info: contact Gary
086-1030418 or garykeane@cregg.ie
Responsibilities
- Work alongside manufacturing engineers and cross funtional engineering teams to identify gaps and implement corrective actions to achieve compliance.
- Execute equipment and process validation activities (IQ/OQ/PQ).
- Revise and maintain quality system records and technical documentation to ensure audit readiness.
- Liaise with supplier sand vendors on NPI and procurement of equipment and materials.
- work on NPI projects - validating new processes and new equipment being introduced to site.
- 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.
- Lean Mfg advantageous - process improvement projects.
- 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+ years of experience in medical device/pharma manufacturing, quality engineering desirable.
- background in process and/or equipment validation (IQ/OQ/PQ) and CAPA resolution.
- project management experience desirable.
- Excellent technical writing and documentation abilities.
- Solid understanding of regulatory requirements. with GMP and/or med device industry
- Strong problem-solving mindset, with the ability to collaborate with engineering teams.
NB* Candidates must hold a valid working visa for Ireland.
For more info: contact Gary
086-1030418 or garykeane@cregg.ie
