Quality Assurance Engineer

Join a fast-growing, MedTech innovator developing next-generation Medical Devices using cutting-edge additive manufacturing.

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

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 xwzovoh 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