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Quality AssuranceMedical DevicesMid
Quality Engineer, Medical Devices
Minneapolis, MNPermanent$95,000 – $120,000Posted 2 weeks ago
About the role
Support design and process quality for Class II/III devices under ISO 13485 and 21 CFR Part 820.
What you’ll do
- Own risk management (ISO 14971) and design controls activities.
- Lead CAPA, NCR, and complaint investigations.
- Support process validation and supplier quality.
- Prepare for and support FDA and notified-body audits.
What you’ll bring
- 4+ years in medical device quality engineering.
- Working knowledge of ISO 13485, EU MDR, and 21 CFR 820.
- ASQ CQE preferred.
- Strong root-cause and statistical analysis skills.
Bektin is an equal-opportunity partner. We present every qualified candidate on merit and keep your details confidential until you approve a submission.
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