Program Manager, Quality, AIS

** 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.

** Job Description*
* ** 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 $-$ 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 Health Care 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 Health Care offers a great work environment, professional development, challenging careers, and competitive compensation. GE Health Care is an Equal…