Quality Assurance Manager

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

Job summary

HERO Recruitment represents an international medical device manufacturer with two Galway sites seeking a hands-on QA/QMS leader to own the QMS in Ireland. You will act as Management Representative, drive ISO 13485, ISO 9001 and 21 CFR Part 820 compliance, and oversee audits, CAPA, supplier qualification, and design assurance in a fast-paced environment.

Ideal candidates bring 5–10 years in medical device QA, strong leadership, and ability to travel for supplier assessments.

Qualifications

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

Responsibilities

• Lead development, implementation, and maintenance of QMS in Ireland.
• Act as the Management Representative for the QMS.
• Ensure QMS processes and documentation meet ISO13485/ISO9001 and 21 CFR Part 820.
• Report on QMS performance and identify opportunities for improvement.
• Serve as liaison with customers and certification bodies for audits.
• Provide leadership on QA matters and ensure management review compliance.
• Oversee document and record control for products and processes.
• Plan and conduct internal quality audits and manage CAPA.
• Review suppliers and support qualification of critical suppliers.
• Be the QA contact for Design Assurance activities.
• Drive continuous improvement initiatives to enhance QMS.
• Supervise staff, including hiring and training where applicable.

Skills

Leadership

Management

Quality mindset

Communication

Tools

FMEA

DOE

SPC

Job description

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 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.

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel