Manufacturing Engineer (Hybrid) – Galway

About the role

We are seeking a Manufacturing Engineer to join a leading medical device company in Galway. The role is hybrid, allowing you to work both on‑site and remotely while collaborating closely with manufacturing, quality, and regulatory teams.

Key responsibilities

• Partner with manufacturing engineers and cross‑functional teams to identify gaps and implement corrective actions for compliance.
• Execute equipment and process validation activities (IQ, OQ, PQ) for new and existing equipment.
• Maintain quality system records and technical documentation to ensure audit readiness.
• Liaise with suppliers and vendors on new product introductions (NPI) and equipment procurement.
• Lead closure of CAPAs and NCRs with robust corrective actions.
• Develop clear SOPs and technical documentation for manufacturing and quality processes.
• Participate in Lean manufacturing and process‑improvement projects.

Required profile

• Degree in Engineering, Quality, or a related discipline.
• Minimum 2 years of experience in medical device or pharmaceutical manufacturing.
• Experience with process/equipment validation (IQ/OQ/PQ) and CAPA resolution.
• Project‑management experience is desirable.
• Strong technical writing and documentation skills.
• Solid understanding of GMP and medical‑device regulatory requirements.
• Valid working visa for Ireland.

Required skills

• IQ/OQ/PQ validation
• CAPA management
• Project management
• Technical writing
• GMP compliance

What we offer

• Opportunity to work on cutting‑edge medical device projects.
• Collaborative environment with cross‑functional teams.
• Hybrid work arrangement.