Senior Quality Manager - Medical Devices & EU MDR Lead

Life Science Recruitment Ltd; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Life Science Recruitment Ltd is seeking a Quality Manager-Medical Devices for a Dublin-based role. You will lead the QMS, oversee regulatory compliance including EU MDR, and manage audits, CAPA, and risk management across suppliers and CMOs.

The role requires a strong background in ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745, with proven leadership and documentation controls. Experience as PRRC is desirable.

Qualifications

• Bachelor's degree in Quality Management, Engineering, Life Sciences, Biomedical Engineering, or a related discipline.
• 5-6+ years of hands-on QA/QMS experience in the medical device industry.
• In-depth knowledge of ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745.
• Proven track record leading CAPA, audits, non-conformances, and technical documentation reviews.
• Excellent cross-functional leadership, analytical problem solving, and document control rigor.

Responsibilities

• Lead the maintenance, implementation, and continuous improvement of the QMS in line with ISO 13485:2016, EU MDR 2017/745.
• Review batch records from CMOs, authorise final batch releases, manage traceability/UDI, and oversee incoming inspection and release procedures.
• Ensure pre-release device conformity checks, maintain technical files and EU Declarations of Conformity, and oversee PMS and vigilance reporting.
• Coordinate internal audits, Notified Body/regulatory inspections, and customer audits; own CAPA, deviation, non-conformance, and complaint investigation workflows.
• Maintain lifecycle risk management files in alignment with ISO 14971:2019, integrating risk controls into design, manufacturing, and supplier changes.
• Qualify, audit, and monitor critical suppliers and CMOs; draft and review Quality Agreements to control outsourced operations.
• Monitor quality KPIs, track trends, and report to senior leadership during Management Reviews.

Skills

Cross-functional leadership

Analytical problem solving

Document control

Education

Bachelor's degree in Quality Management or related

Tools

ISO 13485:2016

ISO 14971:2019

EU MDR 2017/745

Job description

Life Science Recruitment Ltd is seeking a Quality Manager-Medical Devices for a Dublin-based role. You will lead the QMS, oversee regulatory compliance including EU MDR, and manage audits, CAPA, and risk management across suppliers and CMOs.

The role requires a strong background in ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745, with proven leadership and documentation controls. Experience as PRRC is desirable.