Program Manager, Quality, AIS

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

Job Description Summary

This role provides quality oversight for AI and machine learning-enabled medical devices, including SaMD. The position supports the full product lifecycle, from design and development through software release, design transfer and post-market activities. Working across engineering, clinical, regulatory and program teams, the role applies design controls, risk management and quality-system requirements to ensure patient safety, product quality and compliance. It also supports investigations, CAPAs, audit remediation and continuous improvement while using sound technical judgement to resolve complex quality issues.

Roles and Responsibilities

Creates and promotes a strong quality culture by driving quality and compliance activities for AI-enabled medical devices, including Software as a Medical Device (SaMD). Responsible for ensuring compliance with the applicable Quality Management System, driving quality objectives and metrics, and supporting effective quality operating mechanisms across the business. Provides quality oversight throughout the product lifecycle, including new product introduction, design and development, design changes, software releases, design transfer and post-market activities. Ensures quality and regulatory compliance while supporting process effectiveness and efficiency. Develops in-depth knowledge of AI-enabled medical devices and their integration with compatible medical-device platforms. Uses prior experience and technical expertise to support quality strategy, risk-based decision-making, verification and validation, and the effective application of design controls. Partners with software engineering, machine learning, clinical, regulatory, product and program teams to provide quality guidance for AI-enabled medical-device development. Communicates complex quality and technical information clearly and provides guidance to less-experienced team members. Impacts projects, processes and procedures within the quality function and operates with appropriate autonomy. Uses professional judgement to identify and address quality and compliance risks, while seeking senior guidance for complex or high-impact matters when needed. Utilizes technical expertise and analytical thinking to resolve quality issues and support investigations, nonconformances, CAPAs, audit remediation and continuous-improvement activities. Leverages multiple internal sources and cross-functional input to make informed decisions.

Required Qualifications

Bachelor's degree from an accredited university or college (OR a high school diploma / GED with at least 10 years of experience.) 6+ years of experience

Desired Characteristics

• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• Experience supporting AI or machine learning-enabled medical devices, including considerations related to data quality, model performance, traceability, validation, change control and integration with medical-device platforms.
• Experience in quality assurance or design quality for medical devices, including SaMD, with working knowledge of design controls, software lifecycle processes, risk management, verification, validation and post-market quality activities.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $106,400.00-$159,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI).

GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: October 17, 2026

At GE HealthCare, we see possibilities through innovation. We're partnering with our customers to fulfill healthcare's greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.