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Quality Engineer – Medical Devices & Combination Products

Quality Engineer – Medical Devices & Combination Products

Intellectt IncNorth Chicago, Illinois, United States
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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.
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    Product Quality Engineer • North Chicago, Illinois, United States