Senior Quality Engineer - Medical Devices/Pharma
📍 Sturtevant, WI – 100% Onsite
⏳ 6-Month Contract (W2 Only)
About the Role
We are seeking a Quality Engineer to support Operations, Sustaining Engineering, R&D, and New Product Introduction teams. The role focuses on Change Control, CAPA, Design Control, Risk Management, Post-Market Surveillance, and Quality System compliance within a medical device environment.
Key Responsibilities
✅ Support and review Change Control activities for Operations, Engineering, and Design teams
✅ Review technical documentation for accuracy and compliance
✅ Assist with verification, validation, and introduction of product changes and new products
✅ Support supplier quality activities and drive quality improvement initiatives
✅ Lead/support CAPA investigations, nonconformance analysis, deviations, scrap/rework analysis
✅ Contribute to Risk Management activities and updates to risk files
✅ Support regulatory inspections and internal/vendor audits
✅ Ensure adherence to FDA QSR, ISO 13485, GMP, and other medical device regulations
✅ Provide support to Quality Management and cross-functional teams as needed
Minimum Qualifications
🎓 Bachelor’s degree in Engineering, Physical Sciences, or equivalent
🗓 3–5 years of Quality Engineering experience
🏥 6–7 years in Medical Device, Pharmaceutical, or similar regulated industries
🧪 Strong knowledge of:
Preferred Qualifications
⭐ Experience with electromechanical devices
⭐ ASQ Certified Quality Engineer (CQE) or equivalent
⭐ Familiarity with statistical sampling for DV/PV
⭐ Experience with system software/firmware/hardware integration
Technical Skills
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