Quality Engineer - Medical Device Manufacturer

This is a senior‑level Quality Engineering position with a medical device manufacturer located near the Illinois-Wisconsin border. The role oversees all QA/QC functions within a metal fabrication environment.

Client Details

Our client is a premier supplier of medical device solutions for major OEMs, delivering a broad portfolio of metal‑fabricated products and silicone‑handled components. Their capabilities support the production of surgical implants, robotics, orthopaedic devices, and other advanced medical technologies.

Description

• Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards
• Investigate and address customer complaints - CAPA
• Assist with preparing and executing internal and external audits
• Handle document and process controls
• Update documentation and data within the QMS
• Create and direct validations (IQ/OQ/PQ)
• Create PPAP documentation
• Other duties as assigned

Profile

• 5-7+ years of quality experience in medical device
• understanding of ISO13485 and FDA standards
• Experience with metal fabrication, CNC preferred
• GD&T/PPAP experience
• Knowledge of QMS software and associated document control
• Certifications a plus
• Bachelors degree a plus
• Sponsorship is not provided

Job Offer

• Salary ranging from $80,000-$100,000 depending on experience and interviews
• 3 weeks of PTO- accrues from day one
• Full medical benefit plans offered on day one
• Discretionary bonus
• Company paid holidays
• 401(k) matching

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.