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 youll 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 youll 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 were 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 preferred) Additive manufacturing / 3D printing experience would be highly beneficial

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