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.
Principal Quality Engineer in saint paul at Unknown Company
This position is listed as contract and able to be worked remotely.