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

Bachelor’s in science, engineering, or related field; ASQ certification or advanced degree preferred.

5+ years QA experience in medical devices/combination products.

Strong project management, problem-solving, and cross-functional leadership skills.

Familiarity with infusion pumps, autoinjectors, pre-filled syringes, eyecare or biologics preferred.

Location North Chicago, IL

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