Quality Management System Co-Ordinator

Unipharmedtech; Dublin; On-site; 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

Quality Management System Co-Ordinator## Quality Management System Co-OrdinatorApply: Northern Cross: Fonthill: Full time: Posted Today: JR-0000008537Purpose of the roleWe are currently looking for QMS Support Co-Ordinator in Dublin. The role is full time and permanent. It is a hybrid role, requiring a minimum of 3 days onsite. Working hours are from 9am until 5:30pm daily.The role is based primarily across Northern Cross Business Park and Fonthill Business Park in Dublin and travel between sites may be required.***This is an ideal opportunity for someone with 1-2 years experience, looking to gain more exposure in the medical devices industry.*** Role of the departmentThe QCRA Uniphar MedTech department is a support function, offering support services across 10 organisations within the medical device industry. The support offered includes Quality System Management, internal audits to ISO 9001:2015, ISO 1348:2016 standards, as well as regulatory query support (MDR), compliance WDA for the Medicinal product licence and Post Market surveillance. Reporting to the QMS Manager, the Quality Management Systems Co-Ordinator will be responsible for developing an integrated quality management system across the brands. Building on a strong well-established system in place currently, this role will build out our current QMS into a fully integrated system to include ISO 13485, ISO 9001, and relevant regulations. You will be highly motivated, with a passion for Quality Management Systems and Quality Compliance and will support our continued drive towards excellence in service.This is a great opportunity to work for a rapidly growing company and we are seeking someone who is eager to learn and thrive in a fast-paced environment.This role will be based in our office in Northern Cross Business Park, Finglas, however you will be required to travel to other Medtech offices across IOI, UK and Europe **MAIN DUTIES & 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. **QUALIFICATION, EXPERIENCE & SKILLS REQUIRED*** 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* Keen attention to detail* Strives for continuous improvement* Hold a valid Working Permit* Full Clean Driving license preferred **COMPETENCIES*** Excellent written communication skills.* Excellent telephone manner.* Highly organized & efficient – with an ability to multitask.* Excellent interpersonal skills – with an ability to interact with all of staff, management, customers & clients.* An ability to prioritise and work under pressure.* An ability to meet deadlines.