Are you interested in taking the next step in your career with a global leader in the medical device industry? Are you ready to challenge yourself in a fast-paced and high-regulated environment? Are you an experienced quality or manufacturing engineer? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!
Job Description
Our client in Galway, requires an experienced Manufacturing Engineer to support a large upcoming site-wide project. This role will focus on manufacturing process validation, quality system updates, and documentation remediation. You will identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready. You will also be collaborating cross-functionally across Quality, Manufacturing, and Regulatory teams.
Key Responsibilities
- Partner with process owners on the floor to capture and remediate issues.
- Support process validation (IQ/OQ/PQ) and documentation updates.
- Drive CAPA/NCR closure and implement compliant solutions.
- Provide technical writing for quality and manufacturing documents.
- Collaborate cross-functionally to ensure regulatory compliance.
Key Requirements
- Engineering or Quality degree with 5-10 years' med-tech experience.
- Background in remediation, process validation, CAPA, NCRs.
- Strong technical writing and documentation skills.
- Knowledge of 21 CFR Part 820, ISO 13485.
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid public holidays
Location: Galway, Ireland | onsite
