Senior Quality Engineer - Medical Devices / Pharmaceutical Manufacturing

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

3–5 years of Quality Engineering experience

6–7 years in Medical Device, Pharmaceutical, or similar regulated industries

Preferred Qualifications

Technical Skills