🔹 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! 📩