Digital Quality Lead for Software & Cloud

GE HealthCare; Bellevue (WA); On-site; USD 106,000 - 160,000; Full time

Job summary

GE HealthCare in the Pacific Northwest seeks a Lead Specialist, Digital Quality to provide quality leadership and technical expertise for software products, cloud-based solutions, and digital platforms across the software lifecycle.

You will partner with Product, Engineering, Regulatory, Cybersecurity, Privacy, Data/AI, and Quality teams to implement scalable quality practices within Agile, DevSecOps, and cloud environments, ensuring compliance and risk-based controls.

Qualifications

• Bachelor’s degree or 10 years+ relevant experience
• 6+ years of experience in software quality, software engineering, or digital product development
• Experience with Agile, Scrum, DevOps, or DevSecOps
• Strong technical writing, documentation review, and communication skills

Responsibilities

• Provide quality guidance throughout product development, release, deployment, maintenance, change, and retirement activities.
• Support non-medical-device software, SaaS, cloud applications, digital platforms, APIs, reusable components, and software services used by or integrated with regulated medical-device products.
• Evaluate product intended use, software boundaries, and risk to determine quality, regulatory, lifecycle, design control, and documentation requirements.
• Provide oversight of software lifecycle activities, including requirements, design, development, verification, validation, release readiness, configuration management, and change control.
• Review lifecycle and quality documentation for completeness, consistency, traceability, objective evidence, and compliance.
• Partner with product and engineering teams to implement scalable quality practices within Agile, DevSecOps, cloud, and continuous-delivery environments.
• Support software, cybersecurity, operational, data, integration, supplier, and component risk-management activities.
• Participate in design, technical, release-readiness, change-control, and lifecycle milestone reviews as the Quality representative.
• Develop and improve procedures, work instructions, templates, training materials, checklists, and quality records.
• Identify opportunities to simplify, standardize, and automate quality processes and integrate compliance into development workflows.
• Train and coach cross-functional teams on software lifecycle, documentation, risk-management, verification and validation, and QMS expectations.
• Develop and monitor quality metrics and leading indicators to identify trends, risks, and improvement opportunities.
• Support investigations, CAPAs, audits, inspections, and other quality-system activities.
• Collaborate across functions to resolve complex software quality issues and establish sustainable solutions.
• Monitor evolving software, cloud, digital health, AI, cybersecurity, and quality-system requirements and assess their applicability.
• Promote a quality culture focused on prevention, accountability, continuous improvement, and efficient compliance.

Skills

Quality leadership

Regulatory knowledge

Software quality

Documentation

Communication

Independent work

Risk management

Cross-functional collaboration

Agile/DevSecOps

Quality governance

Education

Bachelor’s degree in Engineering/CS/Software Quality or related field

Tools

CI/CD pipelines

Job description

GE HealthCare in the Pacific Northwest seeks a Lead Specialist, Digital Quality to provide quality leadership and technical expertise for software products, cloud-based solutions, and digital platforms across the software lifecycle.

You will partner with Product, Engineering, Regulatory, Cybersecurity, Privacy, Data/AI, and Quality teams to implement scalable quality practices within Agile, DevSecOps, and cloud environments, ensuring compliance and risk-based controls.