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Principal Quality Engineer
Job in
Waukegan, Lake County, Illinois, 60087, USA
Listed on 2026-10-23
Listing for:
Exemplar Global
Full Time
position Listed on 2026-10-23
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Regulatory Compliance Specialist
Job Description & How to Apply Below
Senior / Principal Quality Engineer – FDA Remediation Locations:
Glens Falls, NY | Waukegan / Mundelein / Northfield, IL Work Model:
Onsite Type: W2 Contract Duration: 6-Month Contract (Potential Extension) Industry: Medical Device / Pharmaceutical Key Skills & Responsibilities:
- Hands-on CAPA Execution, Remediation & Closure
- FDA Compliance and Quality System Remediation
- Risk Management Files Review and Remediation
- Design History Files (DHF) & Design Controls
- Medical Device Quality Engineering
- Technical Documentation Review and Remediation
- SOPs, Validation Documentation & Technical File Updates
- FDA Warning Letter Remediation and Legacy Product Compliance
- Cross-functional collaboration with Quality, Engineering, Manufacturing, and Regulatory teams
- Bachelor's degree in Engineering, Science, Quality, or a related field.
- Strong experience in FDA-regulated medical device or pharmaceutical manufacturing.
- Ability to independently execute remediation activities and drive CAPAs to closure.
- Strong technical writing, documentation, and problem-solving skills.
- Must be available for on-site work as required; fully remote is not available.
Experience with legacy medical devices, Risk Management Files, DHF, Design Controls, and FDA remediation programs.
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