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