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:
- Lead and maintain the company QMS in line with ISO 13485:2016 and 21 CFR 820.
- Act as Quality Management Representative and support audit readiness, audit management and closure of actions.
- Oversee quality processes including non-conformances, CAPA and supplier quality.
- Provide quality leadership across the organisation and ensure compliance throughout the product lifecycle.
- Support design, development and manufacturing activities from a quality systems perspective.
- Manage supplier and contract manufacturer oversight, including quality agreements and performance monitoring.
- Drive continuous improvement initiatives across the QMS.
- Perform duties of Person Responsible for Regulatory Compliance (PRRC), where applicable.
Required Experience:
- Level 8 degree in a technical or scientific discipline.
- 8+ years’ experience in a medical device quality role.
- Proven ability to manage an ISO 13485/21 CFR 820 QMS.
- Direct experience interacting with regulatory authorities (FDA, Notified Bodies).
- Strong knowledge of risk management, internal auditing and post-market activities.
Core Skills:
- Strong understanding of quality and regulatory standards.
- Continuous improvement mindset and structured problem-solving.
- Effective decision-making and planning skills.
- High accountability and adaptability in a start-up environment.
- Excellent communication and technical writing skills.
Please note a more detailed job description is available upon request
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
