Quality Systems Manager – Medical Devices

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

Benefits offered by this job

Top salary

Bonus

Pension

Healthcare

Job summary

Life Science Recruitment is seeking a Quality Manager for a Galway-based medical device manufacturer. You will lead the QA program, ensuring ISO 13485, FDA 21 CFR Part 820 compliance, and management of CAPA, audits, and continuous improvement.

Responsibilities include maintaining QMS documentation, internal audits, and acting as the main liaison with customers and certification bodies. Strong leadership and regulatory knowledge are essential.

Qualifications

• 5–10 years of progressive experience in quality assurance and control within medical device manufacturing or related industry.
• Strong leadership and people-management skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Proficiency with quality engineering tools (FMEA, DOE, SPC) and statistical analysis.

Responsibilities

• Establish, implement, and maintain QMS processes in line with ISO 13485, ISO 9001 and 21 CFR Part 820.
• Promote regulatory and customer requirements across the organization and ensure compliance.
• Serve as primary liaison with customers and certification bodies for external audits.
• Provide leadership on QA matters, including quality systems and material disposition.
• Ensure management reviews are conducted per regulatory requirements.
• Oversee document/record control for products, processes and QMS.
• Plan and conduct internal quality audits for compliance.
• Handle CAPA, customer complaints and feedback for timely resolution and improvement.

Skills

Leadership

Regulatory knowledge

Quality tools

Technical writing

Tools

FMEA

DOE

SPC

Job description

Life Science Recruitment is seeking a Quality Manager for a Galway-based medical device manufacturer. You will lead the QA program, ensuring ISO 13485, FDA 21 CFR Part 820 compliance, and management of CAPA, audits, and continuous improvement.

Responsibilities include maintaining QMS documentation, internal audits, and acting as the main liaison with customers and certification bodies. Strong leadership and regulatory knowledge are essential.