Quality Engineer

Quality Engineer - North Chicago, IL

Pay: $57-61/hr | Duration: 6 months (with potential to extend or convert based on performance and budget)

Job Description

The Fountain Group is seeking a Quality Engineer in North Chicago, IL for a promient client of ours. This position will support design transfer, change management, and compliance activities for medical devices and combination products (infusion pumps, tubing, pre-filled syringes, autoinjectors, eyecare, aesthetics devices, etc.). This role ensures adherence to quality systems, regulatory requirements, and corporate policies.

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.
• Collaborate cross-functionally with suppliers, contract manufacturers, and internal teams.
• Drive process improvements, CAPAs, NCRs, and change plan investigations.
  
  

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.
• Must have strong knowledge of ISO 13485, ISO 14971, 21 CFR 4/820, MDR/MDD.
• Experience with combination products preferred.