Principal Quality Engineer (Waukegan)
GROVE TECHNICAL RESOURCES, INC
Hiring: 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
Requirements:
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.
Preferred: Experience with legacy medical devices, Risk Management Files, DHF, Design Controls, and FDA remediation programs.
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