Quality Manager

Quality Manager - Galway

Our client is an international medical device R&D and manufacturing organization with two sites in Galway. This is a hands on leadership role in a fast paced, small scale manufacturing environment.

In this role you will lead and oversee the development, implementation, and maintenance of the QMS in Ireland.

In this role you will:

• Act as the Management Representative for the Quality Management System (QMS).
• Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
• Report on QMS performance and identify opportunities for continuous improvement.
• Serve as the primary liaison with customers and certification bodies for external audits.
• Provide leadership and direction on all QA related matters, including quality systems, compliance, and material disposition.
• Ensure management review meetings are conducted in accordance with regulatory requirements.
• Oversee control of documents and records related to products, manufacturing processes, and the QMS.
• Plan, manage, and conduct internal quality audits to ensure compliance with applicable standards and internal procedures.
• Handle and monitor CAPA, customer complaints, and feedback to ensure timely resolution and continuous improvement.
• Review and approve suppliers of components, raw materials, products, and services impacting product quality, and support qualification of critical suppliers.
• Be Quality point of contact on all Design Assurance activities.
• Drive continuous improvement initiatives to enhance QMS effectiveness and compliance.
• Carry out supervisory responsibilities in accordance with company policies and applicable laws, including interviewing, hiring, training, performance management, and employee development.

Ideally for this role you will have:

• 5-10 years of progressive experience in quality assurance and control within medical device manufacturing or a related industry, with in-depth knowledge of manufacturing processes and quality systems.
• Strong management and leadership skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Demonstrated proficiency in engineering and quality tools (e.g., FMEA, DOE, SPC, and statistical analysis tools).
• Ability to support NPD and design assurance.
• Willingness to travel as required for supplier assessments and other business activities.