Quality Engineer - Medical Device Manufacturing

Jacobs Management Group • Vernon Hills, IL

1d • Onsite

About The Position

My client, a growing healthcare products manufacturer, is hiring a Quality Engineer to keep production compliant and continuously improving, with real influence on product reliability for patients who depend on it. This role offers the opportunity to own quality systems end to end, with real influence over how products get made. You will work cross-functionally with operations, inspectors, and quality consultants as part of a tight-knit team.

Requirements

• Bachelor's degree in quality, industrial, or mechanical engineering
• Working knowledge of 21 CFR Part 820 and 803, and ISO 13485
• Strong technical writing and root cause investigation skills
• Authorized to work in the United States without the need for current or future employer-sponsored work authorization

Nice To Haves

• ASQ certification a plus

Responsibilities

• Support quality validations and investigations, including non-conformances
• Manage quality test methods and validate standards used in production
• Keep production compliant with FDA, GMP, and ISO medical device requirements
• Lead root cause investigations for SCARs, non-conformances, and CAPAs, then develop corrective actions
• Apply engineering and statistical tools to reduce failures and improve reliability
• Support audits and train quality inspectors on clean product release

Benefits

• Medical
• Dental
• Vision
• 401k

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level