We are supporting a Galway based medical device client who are seeking a Senior Quality Assurance Engineer to support quality systems, regulatory compliance and clinical trial activities within a GMP-regulated environment.
Key Responsibilities
1. Maintain and improve the Quality Management System (QMS)
2. Support regulatory inspections, audits and compliance activities
3. Author and maintain quality documentation (procedures, specifications, labels)
4. Provide QA oversight of product release and material disposition
5. Lead and support quality improvement and change control initiatives
6. Support EU clinical trial supply in line with EU CTR 536/2014 and GMP
7. Manage investigations, complaints, CAPAs and technical agreements
8. Conduct and support internal audits
9. Liaise with the Qualified Person to ensure ongoing IMP compliance
Requirements
10. Degree in Engineering, Science or related discipline (Master's/MBA advantageous)
11. 5+ years' QA/QE experience in FDA, GMP or ISO-regulated industries
12. Trained auditor with strong inspection readiness experience
13. Knowledge of clinical trial and medical device regulatory requirements
14. Experience with Lean, Six Sigma and continuous improvement
15. Strong communication, problem-solving and stakeholder management skills