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