Program Manager, Quality, AIS

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $106.4k - $159.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📋 Program Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• 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

• 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

• 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