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Senior Quality Assurance Engineer
Job in
Mundelein, Lake County, Illinois, 60060, USA
Listed on 2026-06-03
Listing for:
3B Staffing
Full Time
position Listed on 2026-06-03
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
- 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
Position Requirements
10+ Years
work experience
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