Join Our Team as a
Quality Control Co-ordinator
in Ireland
At
CWS Cleanrooms Ireland Limite
d, we're looking for a
Quality Control Co-ordinato
r to join our operations team in a
permanen
t role based in
Fonthill, Dublin D2
2. This is a fantastic opportunity to contribute to a growing, regulated manufacturing environment and support the ongoing transition to the
Medical Device Regulation (MDR
)
Quality Control Co-ordinator - Fonthill
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 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
* 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
This
is a full
-time position base
d in Fonthill, D
ublinMonday 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.