QA & Compliance Manager, Medical Devices – Galway

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 in Galway for a medical device manufacturer with a new Galway hub. You will lead the QMS, ensure ISO 13485 and 21 CFR Part 820 compliance, and drive continuous improvement across the organization.

You will oversee audits, CAPA, complaints, and product release activities while mentoring the QA team to achieve excellence in quality systems and regulatory readiness. A proven track record in medical device quality management is required.

Qualifications

• Experience in quality assurance/control in medical device manufacturing or related industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820 or MDR.
• Excellent technical writing and communication skills.

Responsibilities

• Establish, implement and maintain QMS in compliance with regulatory standards.
• Lead external audits and liaise with customers and certification bodies.
• Manage CAPA, complaints and continuous improvement initiatives.
• Supervise and develop QA team and assign work.

Skills

Quality management

Regulatory compliance

Audits

Leadership

Education

Engineering/Science degree

Tools

FMEA

DOE

SPC

Job description

Life Science Recruitment is seeking a Quality Manager in Galway for a medical device manufacturer with a new Galway hub. You will lead the QMS, ensure ISO 13485 and 21 CFR Part 820 compliance, and drive continuous improvement across the organization.

You will oversee audits, CAPA, complaints, and product release activities while mentoring the QA team to achieve excellence in quality systems and regulatory readiness. A proven track record in medical device quality management is required.