Program Manager, Quality, AIS

GE HealthCare

1d•$106,400 - $159,600

About The Position

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.

Requirements

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

Nice To Haves

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.

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.