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 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 13485 and regulatory standards (FDA 21 CFR Part 820)
- 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