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Quality control co-ordinator

CWS Cleanrooms
Quality controller
Posted: 17 October
Offer description

Join Our Team as aQuality Control Co-ordinatorin IrelandAtCWS Cleanrooms Ireland Limited, we're looking for aQuality Control Co-ordinator to join our operations team in apermanent role based inFonthill, Dublin D22. This is a fantastic opportunity to contribute to a growing, regulated manufacturing environment and support the ongoing transition to theMedical Device Regulation (MDR)Quality Control Co-ordinator - FonthillThe 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 documentationMonitor and report in-process results and quality KPIsSupport 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, CAPAsMaintain process documentation and coordinate updatesDrive 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 managementDeliver onboarding and ongoing training sessionsManage hazardous chemicals control on siteParticipate in internal/external audits and ensure audit readinessDevelop and execute test protocols with regulatory-compliant reportingRequired Skills & Experience:Minimum 3 years' QC experience in a regulated Medical Device or Pharmaceutical environmentStrong understanding of EN ISO 13485, ISO 9001, and the Medical Devices RegulationExperience in compliance, risk management, and regulated QC practicesPrimary degree in a scientific discipline (or equivalent experience)Strong communication and organizational skillsAbility to work both independently and collaborativelyFamiliarity with software validation in regulated environments is an advantageLean/CI experience or qualifications desirableThisis a full-time position based in Fonthill, DublinMonday to Friday, standard office hoursAre 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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