AI Medical Device Quality Program Lead

GE Healthcare; United States; Remote; USD 106,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with employer match

Life insurance

Disability insurance

Tuition reimbursement

Paid time off

Job summary

GE HealthCare seeks a quality overs ight professional to oversee AI/ML-enabled medical devices, including SaMD, across the full product lifecycle from design through post‑market activities. You will work with engineering, clinical, regulatory and program teams to ensure patient safety, product quality and regulatory compliance.

You will apply design controls, risk management and QMS requirements, support investigations and CAPAs, and drive continuous improvement while using sound technical

Qualifications

• Bachelor's degree or higher in a related field.
• 6+ years of experience in quality oversight for medical devices.
• Experience with AI/ML-enabled SaMD is highly preferred.

Responsibilities

• Own quality oversight for AI-enabled medical devices across the lifecycle.
• Ensure compliance with QMS, design controls, risk management, and post-market activities.
• Lead investigations, CAPAs, audit remediation, and continuous improvement.
• Collaborate with software, clinical, regulatory, and program teams to guide quality strategy.

Skills

Quality assurance

Regulatory knowledge

Analytical thinking

Communication skills

Education

Bachelor's degree

Job description

GE HealthCare seeks a quality overs ight professional to oversee AI/ML-enabled medical devices, including SaMD, across the full product lifecycle from design through post‑market activities. You will work with engineering, clinical, regulatory and program teams to ensure patient safety, product quality and regulatory compliance.

You will apply design controls, risk management and QMS requirements, support investigations and CAPAs, and drive continuous improvement while using sound technical