Quality Engineering Manager

HERO Recruitment; Galway; On-site; EUR 90,000 - 130,000; Full time

Job summary

HERO Recruitment represents an international medical device organization with two Galway sites seeking a hands-on QA/QMS leader. You will develop, implement and maintain the QMS in Ireland, serving as Management Representative and ensuring regulatory compliance across ISO 13485, ISO 9001 and 21 CFR Part 820.

You will lead internal audits, CAPA handling, supplier qualification, and continuous improvement initiatives while supervising QA teams and aligning with design assurance activities.

Qualifications

• 5–10 years of progressive experience in quality assurance and control within medical device manufacturing or related industries.
• 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 business activities.

Responsibilities

• Act as the Management Representative for the Quality Management System (QMS).
• Ensure QMS processes and documentation comply with ISO 13485, ISO 9001, and 21 CFR Part 820.
• Report on QMS performance and identify opportunities for continuous improvement.
• Serve as primary liaison with customers and certification bodies for audits.
• Provide leadership on all QA matters, including systems, compliance and material disposition.
• Oversee management review meetings as per regulatory requirements.
• Control documents and records related to products, processes and QMS.
• Plan, conduct and manage internal quality audits for compliance.
• Handle CAPA, customer complaints and feedback for timely resolution.
• Review and approve suppliers impacting product quality and support supplier qualification.
• Be Quality point of contact on Design Assurance activities.
• Drive continuous improvement to enhance QMS effectiveness.
• Supervise recruitment, training, performance management and development.

Skills

Management & leadership

Travel flexibility

Quality mindset

Tools

FMEA

DOE

SPC

Statistical analysis

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.