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Join Our Team as a Quality Control Co-ordinator in Ireland!
At CWS Cleanrooms Ireland Limited, we're looking for a Quality Control Co-ordinator to join our operations team in a permanent role based in Fonthill, Dublin D22. This is a fantastic opportunity to contribute to a growing, regulated manufacturing environment and support the ongoing transition to the Medical Device Regulation (MDR).
The Quality Control Co-Ordinator(QC) plays a key role in supporting Operations and the QESH function to ensure ongoing compliance with applicable quality, regulatory, and safety standards. This includes contributing to documentation, process improvements, and audits, as well as supporting the transition to MDR compliance under EN ISO 13485. The role is also responsible for fostering a culture of quality, continuous improvement, and process ownership across the site
Key Responsibilities - include but not limited to:
Provide technical and administrative support to Operations for QMS documentation
Monitor and report in-process results and quality KPIs
Support the QESH team in the transition to the MDR (Medical Device Regulation), including in-house testing, documentation and practical assistance.
Audit and ensure ongoing compliance with QMS standards and site quality practices.
Manage the employee training process, including training records, gap analysis, and QESH- related training initiatives.
Act as the interface between Quality Assurance, Customer Care and Operations.
Lead and support customer complaint investigations, NCs, CAPAs
Maintain process documentation and coordinate updates
Drive lean initiatives and root cause problem-solving through methodologies such as RCCM, 5 Whys, Ishikawa, A3, and 8D.
Assist in product spec development and change management
Deliver onboarding and ongoing training sessions
Manage hazardous chemicals control on site
Participate in internal/external audits and ensure audit readiness
Develop and execute test protocols with regulatory-compliant reporting
Required Skills & Experience
Minimum 3 years' QC experience in a regulated Medical Device or Pharmaceutical environment
Strong understanding of EN ISO 13485, ISO 9001, and the Medical Devices Regulation (MDR)
Experience in compliance, risk management, and regulated QC practices
Primary degree in a scientific discipline (or equivalent experience)
Strong communication and organizational skills
Ability to work both independently and collaboratively
Familiarity with software validation in regulated environments is an advantage.
Hours of Work:
This is a full-time position based in Fonthill, Dublin
Monday to Friday, standard office hours
Are you ready to take the next step in your quality career?
Apply today and become part of a dedicated team working at the forefront of cleanroom innovation and compliance excellence.
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