Principal Quality Engineer

Job Description

Hiring: Senior / Principal Quality Engineer – FDA Remediation

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Locations: Glens Falls, NY | Waukegan / Mundelein / Northfield, IL

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Work Model: Onsite

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Type: W2 Contract

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Duration: 6-Month Contract (Potential Extension)

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Industry: Medical Device / Pharmaceutical

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Key Skills & Responsibilities:

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Hands-on CAPA Execution, Remediation & Closure

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FDA Compliance and Quality System Remediation

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Risk Management Files Review and Remediation

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Design History Files (DHF) & Design Controls

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Medical Device Quality Engineering

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Technical Documentation Review and Remediation

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SOPs, Validation Documentation & Technical File Updates

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FDA Warning Letter Remediation and Legacy Product Compliance

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Cross-functional collaboration with Quality, Engineering, Manufacturing, and Regulatory teams

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Requirements:

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Bachelor's degree in Engineering, Science, Quality, or a related field.

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Strong experience in FDA-regulated medical device or pharmaceutical manufacturing.

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Ability to independently execute remediation activities and drive CAPAs to closure.

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Strong technical writing, documentation, and problem-solving skills.

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Must be available for on-site work as required; fully remote is not available.

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Preferred: Experience with legacy medical devices, Risk Management Files, DHF, Design Controls, and FDA remediation programs.