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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
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
Vacancy posted more than 2 months ago

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