Quality Manager

Hero Recruitment; Galway; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Travel opportunities

Job summary

Hero Recruitment seeks a Quality Manager in Galway for an international medical device R&D and manufacturing organisation. This hands-on leadership role oversees the QMS development, implementation and maintenance at two Galway sites in a fast-paced, small-scale environment.

You will act as Management Representative, ensuring ISO 13485, ISO 9001 and 21 CFR Part 820 compliance, reporting on QMS performance, and driving continuous improvement while liaising with customers and certification bodies.

Qualifications

• In-depth experience leading QA/QC in medical device manufacturing or related industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and related directives.
• Willingness to travel for supplier assessments and business activities.

Responsibilities

• Act as the Management Representative for the QMS and ensure its ongoing effectiveness.
• Develop, implement, and maintain QMS processes and documentation compliant with ISO and regulatory standards.
• Report on QMS performance and drive continuous improvement initiatives.
• Lead internal quality audits and manage CAPA, complaints, and supplier qualification.
• Collaborate with customers and certification bodies during external audits.
• Provide leadership on QA matters and oversee training and development of staff.
• Supervise interviewing, hiring, and performance management as per policy.

Skills

Leadership

Quality management

Regulatory knowledge

Communication

Tools

FMEA

DOE

SPC

Statistical analysis

Job description

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.