Hybrid QMS Coordinator - MedTech Quality & Compliance

Unipharmedtech; Dublin; Hybrid; EUR 40,000 - 58,000; Full time

Job summary

Unipharmedtech seeks a Quality Management System Co-Ordinator in Dublin for a hybrid, full-time role, focused on integrating the QMS across brands and ISO/Regulatory standards. You will manage CAPAs, audits, document control, and KPI reporting within a fast-pacedMedTech environment.

You will travel between sites, support IQMP training, and contribute to continuous improvement while ensuring regulatory compliance across EU MDR, ISO 9001 and ISO 13485 frameworks.

Qualifications

• Third level qualification in science is preferred but not essential.
• Experience in regulatory affairs within Medical Devices / Pharma distribution is desired.
• Understanding of EU MDR 2017/745, ISO 9001 and ISO 13485 and GDP.

Responsibilities

• Maintain and update quality procedures within the quality management system.
• Assist in tracking CAPAs, change controls, and deviations to ensure timely closure.
• Generate reports and dashboards for quality metrics and KPIs.
• Logging of distribution complaints.
• Support audit preparation for regulatory inspections and client audits.
• Internal audits – ISO 9001:2015, ISO 13485:2016, Self inspections and internal procedures.
• Maintain audit schedules and track completion of audit CAPAs.
• Document control / SOP management and support.
• Contribute to KPI reporting for the team.
• Support IQMP training and administration of training courses.

Skills

Quality Mgmt

CAPA tracking

Regulatory affairs

ISO 13485 knowledge

EU MDR 2017/745

Communication

Education

Science degree

Tools

Excel

Word

PowerPoint

Job description

Unipharmedtech seeks a Quality Management System Co-Ordinator in Dublin for a hybrid, full-time role, focused on integrating the QMS across brands and ISO/Regulatory standards. You will manage CAPAs, audits, document control, and KPI reporting within a fast-pacedMedTech environment.

You will travel between sites, support IQMP training, and contribute to continuous improvement while ensuring regulatory compliance across EU MDR, ISO 9001 and ISO 13485 frameworks.