Quality Assurance Lead Engineer

GE HealthCare seeks a Quality Assurance Lead Engineer to drive compliance activities, manage quality systems, and establish quality culture for medical device manufacturing. The role involves regulatory oversight, process improvement, and cross-functional collaboration in a hybrid position based in Wisconsin.

Responsibilities

• Drive compliance activities and establish quality culture for assigned product, site, or region
• Manage total quality management system and track quality metrics for business operations
• Represent organization to external regulatory agencies and champion quality evolution
• Develop and execute quality objectives, metrics, reporting, and operating mechanisms
• Provide guidance to team members and communicate complex quality concepts clearly

Requirements

• Bachelor's degree in engineering or technical discipline, or high school diploma with 7+ years manufacturing/quality experience
• Minimum 3 years experience in regulated industry environments
• Understanding of medical device QMS requirements, FDA CFR 21 Part 820, and ISO 13485
• Knowledge of quality management system tools and continuous improvement methodologies
• Familiarity with design controls, process validation, and CAPA procedures in medical devices
• Strong communication skills across organizational levels
• Ability to work hybrid schedule with three days per week on-site in Waukesha, Wisconsin