Program Manager, Quality, AIS

GE HealthCare

. Drive quality and compliance activities for AI-enabled medical devices, including Software as a Medical Device (SaMD) .

Posted 10/7/2026full-timeRemote • United StatesMid-LevelSenior💰 $106,400 - $159,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance and compliance for AI-enabled medical devices, with a strong focus on Software as a Medical Device (SaMD) and risk management. Proficient in driving quality objectives, verification, validation, and cross-functional collaboration.

Highest-signal resume keywords

Quality Assurance for Medical DevicesSoftware as a Medical Device (SaMD)Risk ManagementProject ManagementStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemVerification and ValidationDesign ControlsSoftware Lifecycle ProcessesData QualityModel PerformanceTraceabilityChange ControlContinuous ImprovementAudit Remediation

Soft Skills

Problem SolvingTeam GuidanceOral CommunicationWritten CommunicationDecision Making

Industry Keywords

AI-Enabled Medical DevicesSaMDPost-Market ActivitiesQuality ObjectivesNonconformancesCAPAsDesign ChangesNew Product IntroductionClinical CollaborationRegulatory Compliance

About the role

Key responsibilities & impact

Drive quality and compliance activities for AI-enabled medical devices, including Software as a Medical Device (SaMD)
Ensure compliance with the applicable Quality Management System and drive quality objectives and metrics
Provide quality oversight throughout new product introduction, design and development, design changes, software releases, design transfer, and post-market activities
Support quality strategy, risk-based decision-making, verification and validation, and application of design controls
Partner with software engineering, machine learning, clinical, regulatory, product, and program teams
Provide quality guidance and communicate complex quality and technical information
Identify and address quality and compliance risks
Resolve quality issues and support investigations, nonconformances, CAPAs, audit remediation, and continuous-improvement activities
Use cross-functional input and internal sources to make informed decisions
Provide guidance to less-experienced team members

Requirements

What you’ll need

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
Strong oral and written communication skills
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 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
Working knowledge of design controls, software lifecycle processes, risk management, verification, validation, and post-market quality activities
Legally authorized to work in the United States
Willingness to successfully complete a drug screen, as applicable

Benefits

Comp & perks

Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
Medical, dental, and vision insurance
Paid time off
401(k) plan with employee and company contribution opportunities
Life, disability, and accident insurance
Tuition reimbursement
Professional development
Challenging careers
Competitive compensation