Lead Specialist, Quality, Digital

About the role

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.

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.

Requirements

• 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.

Skills