Quality Systems Coordinator — Hybrid (Dublin)

Uniphar Group; South Dublin; Hybrid; EUR 42,000 - 52,000; Full time

Job summary

Uniphar Group in Dublin is seeking a QMS Support Co-Ordinator. This full-time, permanent, hybrid role requires a minimum of 3 days onsite with hours 9:00-17:30.

Travel between Northern Cross and Fonthill sites may be required, and the role involves building an integrated QMS across ISO 13485/ISO 9001 and related regulations. You will support quality procedures, CAPA tracking, audits, KPI reporting, and IQMP training within the MedTech department, reporting to the QMS Manager.

Qualifications

• Third level qualification in science preferred but not essential.
• Excellent PC skills (Word, Excel, PowerPoint).
• Experience with administrative duties is an advantage.
• Experience in Regulatory Affairs within Medical Devices/Pharma Distribution.
• Understanding of EU MDR Regulation 2017/745, ISO 9001 and ISO 13485, GDP.
• Strong communication, interpersonal and prioritising skills.
• Hold a valid Working Permit and 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.
• Contribute to KPI reporting and training administration.
• Support onboarding of additional business units into the QMS.

Skills

Excellent PC skills

Regulatory affairs

Documentation

Auditing

Communication

Attention to detail

Education

Science degree preferred

Job description

Uniphar Group in Dublin is seeking a QMS Support Co-Ordinator. This full-time, permanent, hybrid role requires a minimum of 3 days onsite with hours 9:00-17:30.

Travel between Northern Cross and Fonthill sites may be required, and the role involves building an integrated QMS across ISO 13485/ISO 9001 and related regulations. You will support quality procedures, CAPA tracking, audits, KPI reporting, and IQMP training within the MedTech department, reporting to the QMS Manager.