Quality Engineering Manager – QMS & Compliance Leader

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

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.