Quality Engineer

Join a fast-growing, MedTech innovator developing next-generation Medical Devices using cutting-edge additive manufacturing. This is a hands-on Quality Engineer role where you’ll play a key part in maintaining and improving an ISO 13485 QMS while supporting product development, validation, and regulatory activities ahead of major commercial launches. What you’ll be doing: • Own and maintain the QMS (ISO 13485) • Manage document control, CAPAs, and change control • Support NPD, validation, and testing activities • Conduct internal audits and support external/regulatory audits • Work closely with engineering and clinical teams What we’re looking for: • 2+ years in medical device quality • Strong knowledge of ISO 13485, MDR, and/or 21 CFR 820 • Experience with design controls & risk management • Background in medical devices (Class II/III) • Additive manufacturing / 3D printing experience would be highly beneficial