SENIOR QUALITY ASSURANCE ENGINEER
3B Staffing LLC
- 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
- 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
Vacancy posted 4 days ago
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