Senior AI Medical Device Quality Program Manager

MS0309 GE Healthcare IITS USA Corp.; United States; Remote; USD 106,000 - 160,000; Full time

Job summary

GE HealthCare in the United States seeks a quality leader to oversee AI/ML-enabled medical devices, including SaMD, guiding design controls, risk management and QMS compliance across the full product lifecycle.

You will collaborate with software, clinical, regulatory, and program teams to resolve complex quality issues, drive CAPAs, investigations and continuous improvement, with a strong emphasis on patient safety and product quality.

Qualifications

• Bachelor's degree and 6+ years of experience or equivalent.
• Experience with AI/ML-enabled medical devices, including SaMD.
• Knowledge of design controls, risk management and quality systems.
• Strong communication skills and cross-functional collaboration.
• Ability to drive CAPAs, investigations and continuous improvement.

Responsibilities

• Creates and promotes a strong quality culture by driving quality and compliance for AI-enabled medical devices and SaMD.
• Ensures compliance with the Quality Management System and supports quality operating mechanisms.
• Provides quality oversight across the product lifecycle from design through post-market activities.

Skills

Quality mindset

Communication skills

Problem analysis

Project management

AI/ML medical devices

Regulatory knowledge

Education

Bachelor's degree

HS diploma + 10 years experience

Job description

GE HealthCare in the United States seeks a quality leader to oversee AI/ML-enabled medical devices, including SaMD, guiding design controls, risk management and QMS compliance across the full product lifecycle.

You will collaborate with software, clinical, regulatory, and program teams to resolve complex quality issues, drive CAPAs, investigations and continuous improvement, with a strong emphasis on patient safety and product quality.