Quality Manager-Medical Devices
Our Dublin based client are currently recruiting for a Quality Manager to join their team on a permanent basis. As Quality Manager you willlead, maintain, and continuously elevate the Quality Management System (QMS). You will hold direct oversight of quality assurance, risk management, supplier quality, and regulatory obligations as a legal manufacturer of medical devices.
Where formally appointed, you will also serve as the designated Person Responsible for Regulatory Compliance (PRRC) under Article 15 of Regulation (EU) 2017/745 (EU MDR).

Responsibilites:

• Quality Management System (QMS): Lead the maintenance, implementation, and continuous improvement of the QMS in accordance with ISO 13485:2016, EU MDR 2017/745, and applicable FDA regulations (QMSR).
• Legal Manufacturer Oversight: Review batch records from Contract Manufacturing Organisations (CMOs), authorise final batch releases, manage traceability/UDI, and oversee incoming inspection and release procedures.
• PRRC Duties (EU MDR Art. 15): Ensure pre-release device conformity checks, maintain technical files and EU Declarations of Conformity, and oversee post-market surveillance (PMS) and vigilance reporting.
• Audits & CAPA: Coordinate internal audits, Notified Body/regulatory inspections, and customer audits. Own the CAPA, deviation, non-conformance, and complaint investigation workflows.
• Risk Management: Maintain lifecycle risk management files in full alignment with ISO 14971:2019, integrating risk controls into design, manufacturing, and supplier changes.
• Supplier & CMO Management: Qualify, audit, and monitor critical suppliers and CMOs; draft and review Quality Agreements to ensure tight control of outsourced operations.
• Management Reviews: Monitor quality KPIs, track trends, and report directly to senior leadership during Management Reviews.

• Bachelor’s degree in Quality Management, Engineering, Life Sciences, Biomedical Engineering, or a related discipline.
• 5–6+ years of hands-on experience in QA/QMS within the medical device industry.
• In-depth working 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.

• Prior experience acting as an EU MDR Article 15 PRRC.
• Working familiarity with FDA QMSR inspections and MDSAP frameworks.
• Experience managing CMOs, outsourced manufacturing, and supplier audits.
• Certified ISO 13485 Lead Auditor.