Manager - Quality Engineer - Medical Device

Job Title:

Quality Engineer– Medical Devices Location :
Rosemont, IL Duration: 6 Months Contract

Job Summary:

We are seeking an experienced Quality Engineer with a strong background in medical devices and machining operations. This role will lead quality system development, support design controls, manage risk activities, and ensure compliance with 21 CFR 820, ISO 13485, and EN standards. The candidate will also mentor teams and drive continuous improvement initiatives.

• Lead and continuously improve Quality Systems for R&D in compliance with 21 CFR 820, ISO 13485, and EN requirements.
• Ensure robust implementation of Design Controls and maintain Design History Files (DHF).
• Apply Six Sigma and statistical tools to support product development and process control.
• Oversee machining-related quality processes, validation, and inspection controls.
• Maintain quality metrics, reports, and management review data.
• Mentor and provide technical direction to Quality Engineers and cross-functional teams.
• Support audits, regulatory inspections, and continuous improvement initiatives.

• Bachelor’s degree in Engineering or related field.
• 8+ years of experience in medical device quality engineering, including machining processes.
• 3+ years of managerial or team leadership experience.
• Strong knowledge of Design Control, Risk Management (ISO 14971), and DHF management.
• Experience with statistical analysis and Six Sigma methodologies.