Quality Engineer
Quality Engineer focuses on managing document control, capas, and change control.
What the role involves
- Managing document control, CAPAs, and change control.
- Supporting NPD, validation, and testing activities.
- Support external/regulatory audits.
- Conduct internal audits.
Skills and requirements
- Strong knowledge of ISO 13485, MDR, and/or 21 CFR 820.
- Experience with design controls & risk management.
- 3D printing experience would be highly beneficial.
Candidate fit
- technical judgement, safe working habits, careful diagnostics, and practical problem-solving
Additional role context
- Tech innovator developing next-generation Medical Devices using cutting-edge additive manufacturing.
- Work closely with engineering and clinical teams.
- 2+ years in medical device quality.
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