Job Description
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!
#J-18808-Ljbffr