Quality Engineer

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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

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