Principal Quality Engineer

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.