- Serves as the validation subject matter expert for the Agile Team by providing business workflow clarification, validation guidance and regulatory context.
- Develops behavior-driven development scenarios and supports the creation of automated and manual test coverage aligned with acceptance criteria, intended use, applicable standards and industry practices.
- Supports the team when the Product Owner is unavailable by clarifying documented business processes, user workflows, dependencies, risks and acceptance criteria while escalating decisions requiring formal Product Owner accountability.
- Participates and facilitates (as required) in PI planning, backlog refinement, iteration planning, reviews, retrospectives, and other Agile ceremonies needed to support timely delivery.
- Steps in for the Product Owner when requested to clarify business process expectations, user workflows, dependencies, risks, acceptance criteria, and regulatory considerations that affect committed work.
- Proactively helps to prevent defects by embedding quality at the source and incorporating validation, risk, regulatory, traceability and testability considerations early in the development lifecycle. Reviews user stories, defects, features, enablers and other work items before Product Owner review to ensure that acceptance criteria and associated test scenarios provide appropriate coverage and reduce the need for extensive downstream manual testing.
- Collaborates with Product Managers, Product Owners, Agile team members and others to ensure work items support intended use and agreed business value.
- Creates and refines user stories, defects, acceptance criteria, and test scenarios from a software verification and validation perspective.
- Develops robust, risk-informed test scenarios that address representative use, normal and exception workflows and applicable negative and boundary conditions.
- Supports automated testing, reviews test output and confirms that results are complete, objective and acceptable across applicable environments.
- Drives the development of clear, testable, and risk-informed acceptance criteria for user stories and defects.
- Performs ad hoc testing and workflow-based exploratory testing throughout the development cycle to provide timely feedback and identify defects, requirement ambiguity, workflow conflicts, validation gaps and documentation concerns.
- Supports validation planning, documentation, review, execution and evidence retention in accordance with quality system procedures.
- Promotes quality, inspection readiness, shared ownership, and continuous improvement while mentoring cross-functional team members on validation expectations.
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