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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-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 Quality Management System (QMS)
* Create, manage, and maintain quality documentation including SOPs, protocols, reports, and records
* Act as a key interface with customers, ensuring all quality expectations are understood and met
* Collaborate with multiple departments to embed a culture of quality across the organization
* Lead and coordinate internal audits, CAPA, SCAR activities
* Support lab testing, engineering evaluations, and new product/process studies
Qualifications & Experience
* Degree in Engineering, Quality, or Science
* Solid experience with ISO and regulatory standards (FDA 21 CFR Part 11)
* Hands-on knowledge of statistical tools (Excel, Minitab, SPS)
* Experience conducting audits and managing CAPAs
* Proven success in leading quality improvement initiatives
* Minimum of 3 years' experience in a regulated medical device or manufacturing environment
* Strong analytical, communication, and interpersonal skills
* Ability to work both independently and in a fast-paced, collaborative team setting
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