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.