Principal I, Research & Development Quality Assurance (T)
Core
Principal QA Engineer providing oversight, review, and governance for Digital Health software tools and systems in a regulated environment.
Role type
Principal I, Research & Development Quality Assurance
Builds
Validated Digital Health software tools and customer-facing supporting systems
Domain
Digital Health / Medical Devices / Regulated Software
Required skills
QA oversight, CSV/CSA risk-based approaches, GxP impact assessments, change control, ISO 13485 environment experience, Agile integration, requirements review, audit readiness, strategic guidance
Preferred skills
Cloud operations support, Agile tools (Jira/ServiceNow), audit/inspection support
Technologies
Jira, ServiceNow
Responsibilities
Provide QA oversight for Digital Health software tools and customer-facing supporting software systems and infrastructure; Apply CSV and CSA risk-based approaches to review and assess validation and testing strategies; Perform GxP and impact assessments to help determine validation scope and testing needs; Assess and support change control activities, including validation and risk impact assessments; Ensure systems remain in a validated state throughout their lifecycle through oversight and governance; Integrate QA and validation oversight activities into Agile sprints and releases; Review requirements and user stories for quality, testability, and traceability; Review and approve testing evidence, defect assessments, and retesting outcomes as appropriate; Collaborate with IT and development teams to support compliant system delivery; Support audit and inspection readiness activities as needed; Provides strategic guidance for post-market support activities; Operates independently on complex tasks and contributes to critical QA technical decisions.
Seniority
Principal, hands-on IC with strategic guidance