PROJECT DESCRIPTION
Our client in Galway are seeking an experienced Quality Engineer to support their operations, focusing on day-to-day line management and non-conformances. The successful candidate will be based on-site and work directly with other quality engineers and technicians to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
RESPONSIBILITIES
- Partner with process owners and quality technicians 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.
REQUIREMENTS
- Engineering or Quality degree with 3–5 years’ med-tech experience
- Background in remediation, CAPAs, NCRs.
- Strong technical writing and documentation skills.
- Knowledge of 21 CFR Part 820, ISO 13485.
FIXED TERM CONTRACT
12 MONTHS WITH AN EXTENSION
SALARY
PENSION
HEALTHCARE
HOLIDAYS
FULL TIME ONSITE IN GALWAY
MEDTECH EXPERIENCE REQUIRED
3 - 5 YEARS EXPERIENCE REQUIRED