Note: The job is a remote job and is open to candidates in USA. GE HealthCare is a healthcare technology company seeking a Program Manager, Quality, AIS. This role provides quality oversight for AI and machine learning-enabled medical devices, including Software as a Medical Device, across the full product lifecycle. The position partners with cross-functional teams to ensure compliance, manage risks, support investigations and CAPAs, and drive continuous improvement.
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
Skills
- 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
- We will not sponsor individuals for employment visas, now or in the future, for this job opening
- GE HealthCare will only employ those who are legally authorized to work in the United States for this opening
- 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
Benefits
- Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
- Medical, dental, and vision coverage
- Paid time off
- A 401(k) plan with employee and company contribution opportunities
- Life, disability, and accident insurance
- Tuition reimbursement
- Professional development
- Great work environment
Company Overview