Quality Manager
Medical Device Sector | Galway
A Galway based medical device company driving cutting-edge innovation is seeking an experienced Quality Manager to lead and manage its Quality Management System (QMS). This is a hands-on leadership role within a dynamic, fast-moving team working on products from early development through to commercialisation. A competitive package, including share options, is available for the right candidate.
Key Responsibilities:
1. Lead and maintain the company QMS in line with ISO 13485:2016 and 21 CFR 820.
2. Act as Quality Management Representative and support audit readiness, audit management and closure of actions.
3. Oversee quality processes including non-conformances, CAPA and supplier quality.
4. Provide quality leadership across the organisation and ensure compliance throughout the product lifecycle.
5. Support design, development and manufacturing activities from a quality systems perspective.
6. Manage supplier and contract manufacturer oversight, including quality agreements and performance monitoring.
7. Drive continuous improvement initiatives across the QMS.
8. Perform duties of Person Responsible for Regulatory Compliance (PRRC), where applicable.
Required Experience:
9. Level 8 degree in a technical or scientific discipline.
10. 8+ years' experience in a medical device quality role.
11. Proven ability to manage an ISO 13485/21 CFR 820 QMS.
12. Direct experience interacting with regulatory authorities (FDA, Notified Bodies).
13. Strong knowledge of risk management, internal auditing and post-market activities.
Core Skills:
14. Strong understanding of quality and regulatory standards.
15. Continuous improvement mindset and structured problem-solving.
16. Effective decision-making and planning skills.
17. High accountability and adaptability in a start-up environment.
18. Excellent communication and technical writing skills.
Please note a more detailed job description is available upon request