Hybrid QMS Coordinator – MedTech (Dublin)

uniphar; Ireland; Hybrid; EUR 36,000 - 60,000; Full time

Job summary

The QMS Support Co-Ordinator at Uniphar MedTech in Dublin is a full-time, permanent role offering a hybrid work pattern with three days onsite. The position involves developing an integrated quality management system across brands, ISO 13485 and ISO 9001 compliance, and supporting regulatory queries (MDR).

Based in Northern Cross/Fonthill, the role requires 1-2 years' experience in quality or regulatory affairs within medical devices, strong IT skills, and a willingness to travel between Irish

Qualifications

• A third level qualification in science is preferred but not essential.
• Excellent PC skills, including Word & Excel PowerPoint etc.
• Previous experience of administration duties an advantage
• Experience working within a Regulatory Affairs role within Medical Devices / Pharma Distribution
• Understanding of EU MDR Regulation 2017/745, ISO 9001, ISO 13485 and GDP
• Strong communication, interpersonal and prioritising skills
• Hold a valid Working Permit
• Full Clean Driving license preferred

Responsibilities

• Maintain and update quality procedures within the quality management system.
• Assist in the tracking of CAPAs, change controls, and deviations to ensure timely closure.
• Generate reports and dashboards for quality metrics and KPIs.
• Logging of distribution complaints.
• Support with 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
• Contributing to preparation of KPI reporting for the team.
• Supporting on administrative tasks as required.
• Support with IQMP training and administration of training courses.
• Provide cover & support in other areas of the team during periods of high volume or annual leave, such as Recalls / FSNs or product complaint reporting for current Business units. Manage the recall and complaint reporting for the European Business units.
• Support in the administrative implementation of and onboarding of additional business units into the QMS (IQMP)
• Any other quality duties which may arise.

Skills

Regulatory affairs

Quality management

ISO 13485

ISO 9001

EU MDR

Documentation control

Driving license

MS Office

Education

Science degree

Tools

MS Word

MS Excel

PowerPoint

Job description

The QMS Support Co-Ordinator at Uniphar MedTech in Dublin is a full-time, permanent role offering a hybrid work pattern with three days onsite. The position involves developing an integrated quality management system across brands, ISO 13485 and ISO 9001 compliance, and supporting regulatory queries (MDR).

Based in Northern Cross/Fonthill, the role requires 1-2 years' experience in quality or regulatory affairs within medical devices, strong IT skills, and a willingness to travel between Irish