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
🎓 Bachelors degree in Engineering, Physical Sciences, or equivalent
🗓 35 years of Quality Engineering experience
🏥 67 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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