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 with a background in process validation and/or CAPA implementation? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!
Job Description
Our client in Galway, requires experienced Remediation Quality Engineers / Manufacturing Engineers to support a site-wide remediation program following an FDA 483. These roles will focus on manufacturing process validation, quality system updates, and documentation remediation. Consultants will be based onsite and work directly with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
The project will involve tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes. Consultants must be able to take a problem statement through to a compliant solution, 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
