Quality Engineer

Job Summary

A company is looking for a Quality Engineer in North Chicago, IL.

Key Responsibilities

• Lead quality and compliance aspects of design transfer and on-market change management
• Ensure design control documentation, risk management, and change control compliance
• Support regulatory inspections, internal audits, and act as QA subject matter expert

Required Qualifications

• Bachelor's in science, engineering, or related field is required (advanced degree/ASQ certification preferred)
• 8+ years in medical device industry; 5+ years in Quality Assurance is required
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR 4/820, MDR/MDD
• Experience with combination products preferred