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