Staff/Senior Quality Engineer

Senior Quality Engineer – Medical Devices & IVDs Are you an experienced Senior Quality Engineer looking for a career-defining opportunity in the medical technology space? We’re hiring! Join an innovative and rapidly growing company that specializes in medical devices . This is your chance to play a key role in ensuring compliance with ISO 13485 / MDSAP standards while driving excellence across design, development, and manufacturing processes. Location: Inverness, Highlands Industry: Medical Devices | IVD | Quality Engineering What You’ll Be Doing: ✅ Develop and maintain technical documentation to meet regulatory & quality standards. ✅ Lead the transition to a full eQMS system and provide training. ✅ Manage design control processes for Class II/III medical devices & Class C IVDs . ✅ Support regulatory submissions and market authorization applications. ✅ Conduct internal audits, risk management, and CAPA investigations . ✅ Provide quality oversight to suppliers & contractors . ✅ Organize and lead Quality Management Review Board meetings. What We’re Looking For: ✔ 5+ years of experience in Quality Engineering within Medical Devices or IVDs. ✔ Strong knowledge of ISO 13485, MDSAP, and ISO 14971 . ✔ Expertise in design controls, risk management, and regulatory compliance . ✔ Proven experience working within an FDA-compliant QMS . ✔ Excellent documentation skills and ability to communicate complex regulations. Bonus Points For: Experience in medical device (MD) or IVD product development . Lean/Six Sigma certification. ISO 13485:2016 Internal Auditor certification. This is a fantastic opportunity to drive real impact in a company pushing the boundaries of medical innovation. If this sounds like you—or someone in your network—let’s connect!