SENIOR QUALITY ASSURANCE ENGINEER

3B Staffing LLC

Mundelein, IL

Medical device design controls expertise (21 CFR 820.30 / ISO 13485)
Direct experience reviewing and auditing DHFs , not just authoring documents
Strong working knowledge of ISO 14971 risk management , including linkage of hazards, risk controls, and residual risk
Experience supporting or remediating DHFs in response to:
- FDA inspections
- CAPAs
- Notified Body or internal audits
Ability to assess traceability and consistency across the DHF , not just document presence
Hands-on experience identifying regulatory gaps vs. procedural nonconformities
Comfortable working in partially remediated or legacy DHFs

Ideal Candidate Profile

Senior quality/regulatory professional (not entry-level)
Prior experience as:
- DHF auditor / reviewer
- Design controls SME
- Quality engineer supporting FDA-regulated devices
Able to work independently, escalate findings clearly, and document gaps concisely
Strong written communication skills for audit-facing outputs

Apply

Vacancy posted 2 days ago

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