Quality Engineer - Medical Devices & Combination ProductsIntellectt Inc • North Chicago, IL, US
Quality Engineer - Medical Devices & Combination Products
Intellectt Inc • North Chicago, IL, US
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job_description.job_card.job_descriptionBachelor'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.
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 :
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