Quality Management System Co-Ordinator

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

Purpose of the role

We 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 department

The 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.

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