Quality Systems Engineer Galway, Ireland | 15 month contract Full-Time £50,000 DOE Are you passionate about medical innovation and driving excellence in quality systems?
Join a cutting-edge team in Galway that's shaping the future of implantable medical device coatings.
We're on the lookout for a Quality Systems Engineer who will play a key role in ensuring the highest quality standards in our R&D operations and beyond.
About the Role As a Quality Systems Engineer, you'll be at the heart of our innovation engine—managing and evolving our ISO 13485-compliant Quality Management System.
You'll collaborate cross-functionally with R&D, manufacturing, and customer-facing teams to ensure regulatory compliance and deliver exceptional product quality.
Key Responsibilities Oversee and continuously improve the ISO 13485 Quality Management System (QMS)Create, manage, and maintain quality documentation including SOPs, protocols, reports, and recordsAct as a key interface with customers, ensuring all quality expectations are understood and metCollaborate with multiple departments to embed a culture of quality across the organizationLead and coordinate internal audits, CAPA, SCAR activitiesSupport lab testing, engineering evaluations, and new product/process studiesQualifications & Experience Degree in Engineering, Quality, or ScienceSolid experience with ISO 13485 and regulatory standards (FDA 21 CFR Part 820)Hands-on knowledge of statistical tools (Excel, Minitab, SPS)Experience conducting audits and managing CAPAsProven success in leading quality improvement initiativesMinimum of 3 years' experience in a regulated medical device or manufacturing environmentStrong analytical, communication, and interpersonal skillsAbility to work both independently and in a fast-paced, collaborative team setting
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