Lead Specialist, Quality, Digital

Location: WA07-01-Bellevue-1100-112th Avenue NE, Waukesha, IL03-01-Chicago-500 W Monroe St

Time Type: Full time

Job Description

Job Description Summary

The Lead Specialist, Digital Quality provides quality leadership and technical expertise for software products, cloud-based solutions, digital platforms, and software services developed within the Pacific Northwest Science & Technology Organization.

This role partners with Product, Engineering, Regulatory, Cybersecurity, Privacy, Data/AI, and Quality teams to establish practical, risk-based controls throughout the software lifecycle. The Lead Specialist serves as a trusted advisor, translating Quality Management System requirements into scalable and efficient development practices.

Job Description

Roles and 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 the appropriate 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.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Software Engineering, Quality, Life Sciences, or a related technical discipline; OR a high school diploma/GED with at least 10 years of relevant experience.
• 6+ years of experience in software quality, software engineering, design assurance, quality systems, regulatory compliance, or digital product development.
• Experience supporting Agile, Scrum, DevOps, DevSecOps, or similar software-development methodologies.
• Knowledge of software lifecycle principles, including requirements, design, development, verification, validation, configuration management, release management, and change control.
• Experience translating quality-system requirements into practical processes for product and engineering teams.
• Strong technical writing, documentation review, analytical, problem-solving, and communication skills.
• Ability to work independently, exercise sound judgment, and identify when escalation or additional expertise is needed.

Desired Characteristics

• Experience in medical devices, healthcare technology, digital health, or another regulated software environment.
• Experience supporting both regulated medical-device software and non-medical-device software.
• Experience with cloud-native applications, SaaS, APIs, microservices, reusable components, or software platforms.
• Familiarity with applicable standards and regulations, including ISO 13485, IEC 62304, ISO 14971, IEC 82304-1, FDA software expectations, cybersecurity requirements, and software-validation principles.
• Experience with software risk management, design and change control, verification and validation, traceability, supplier or component management, and release readiness.
• Familiarity with CI/CD pipelines, software repositories, automated testing, and electronic quality evidence.
• Experience supporting AI/ML-enabled software, data platforms, or cloud-based healthcare applications.
• Experience developing procedures, templates, training, quality records, or process improvements.
• Strong project-management and stakeholder-influencing skills.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $106,400.00-$159,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.