Lead Specialist, Quality, Digital
Core
Lead quality specialist for software products, cloud solutions, and digital platforms within the Pacific Northwest Science & Technology Organization, establishing risk-based controls throughout the software lifecycle.
Role type
Senior IC quality assurance specialist (software lifecycle & regulatory compliance)
Builds
Scalable quality practices, documentation, and compliance frameworks for Agile/DevSecOps environments
Domain
Healthcare technology / Regulated software / Digital health
Required skills
Software lifecycle management, Agile/Scrum/DevOps, risk management, regulatory compliance translation, technical writing, analytical problem-solving
Preferred skills
Medical device software experience, cloud-native/SaaS/APIs, ISO 13485/IEC 62304/FDA knowledge, CI/CD pipelines, AI/ML software validation, process automation
Technologies
Agile, Scrum, DevOps, DevSecOps, CI/CD, SaaS, APIs, microservices, cloud platforms, automated testing
Responsibilities
Provide quality guidance across product development, release, deployment, and retirement; Evaluate software boundaries and risks to determine quality/regulatory requirements; Review lifecycle documentation for compliance and traceability; Partner with engineering to implement scalable quality practices in Agile/DevSecOps; Develop procedures, templates, and training materials; Monitor quality metrics and support investigations/CAPAs/audits; Coach cross-functional teams on QMS expectations.
Seniority
Senior, hands-on IC