Quality Engineer - Medical Devices & Combination Products

Quality Engineer – Medical Devices & Combination Products

Job Description : The Quality Engineer ensures medical devices and combination products (e.g., auto-injectors, infusion pumps, biologics, pre-filled syringes, injection-molded disposables) meet global quality standards from development through manufacturing and post-market. Responsible for compliance with ISO 13485, ISO 14971, 21 CFR 820 / 4, EU MDR, and FDA regulations, including remediation and consent decrees.

Responsibilities

• Lead design transfer, on-market change management, and supplier / third-party quality (CAPA / SCAR, supplier qualification, TPM).
• Oversee validation and engineering activities (IQ / OQ / PQ, TMV, DOE, Master Validation Plans).
• Apply risk management tools (DFMEA / PFMEA) to drive product quality.
• Mentor teams, support audits / inspections, and implement process improvements.
• Drive cross-functional projects, QMS remediation, change management, and audit readiness.

Qualifications

Location

North Chicago, IL

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