Quality Control Co-ordinator

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.

Lean / CI experience or qualifications desirable

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.