Quality Engineers
Design Controls, CAPA, Risk Management.
01 —Role overview
Quality Engineers own the design controls, risk management, and quality systems that keep medical devices safe and compliant under ISO 13485 and FDA 21 CFR Part 820.
02 —Key responsibilities
What you'll do.
- 01Drive design controls per 21 CFR 820.30 and ISO 13485
- 02Author and maintain DHF, DMR, DHR documentation
- 03Lead risk management activities (ISO 14971)
- 04Investigate complaints and drive CAPAs to closure
- 05Support audits, 510(k) reviews, and inspections
03 —Skills & tooling
In demand.
Design ControlsCAPAISO 13485/QMSISO 1497121 CFR 820FDADHFRisk Management
04 —Experience
Typical range
3–10 years
05 —Related roles
More in Medical Devices.
→ Let’s talk
Hiring a Quality Engineer?
Pre-screened candidates ready to deploy. Tell us your timeline.