The Senior Software QA Tester is responsible for leading test strategy, execution, and quality outcomes for Alimentiv's regulated medical imaging software and hardware products, bringing deep regulated software testing expertise and operating with minimal day-to-day supervision. This role applies deep expertise in regulated software testing to ensure that complex medical imaging software and hardware products meet Alimentiv’s quality, compliance, and validation requirements throughout the software development lifecycle. As a senior practitioner within the QA team, this role leads process improvement initiatives, mentors more junior testers, and guides the adoption and improvement of the shared automation framework.
- Own test strategy and coverage decisions, applying risk-based approaches to determine scope and depth of testing.
- Define test objectives, entry and exit criteria, and test coverage based on requirements, risk, and regulatory context, serving as the technical authority on testing approach.
- Lead sprint planning and backlog refinement contributions, proactively surfacing quality risks to the development team.
- Evaluate testability of features and architectural decisions during design and development phases, advising the development team on quality risks before implementation.
- Coordinate test environment requirements with IT and infrastructure teams to ensure readiness ahead of planned test cycles.
- Lead manual and automated test execution across functional, regression, performance, and user acceptance testing phases.
- Execute complex or high-risk test scenarios requiring deep technical judgment, including cross-system integration testing and validation-critical test cases.
- Apply and extend the established automation framework to build and maintain automated test scripts using tools such as Selenium and AccelQ.
- Execute API testing using tools such as Postman and JMeter to validate integration and service-level behavior.
- Provide quality status updates and release readiness assessments to project and product management with documented quality risk rationale.
- Lead defect lifecycle management, including logging, triage, severity and priority classification, and resolution follow-through in Jira.
- Serve as the technical escalation point for complex defect investigation and provide guidance to more junior testers on complex defects.
- Conduct root cause analysis on defect patterns and escalate systemic concerns to development and project leadership as appropriate.
- Ensure defect records are accurate, complete, and traceable to requirements and test cases throughout the project lifecycle.
- Own validation documentation, including traceability matrices, test protocols, and test summary reports in compliance with CSV, CSA, GAMP5, and CFR 21 Part 11.
- Ensure changes to validated documentation or formal test protocols are submitted for appropriate review and approval before implementation.
- Support regulatory audits and client quality reviews by providing evidence of testing practices and validation coverage.
- Support audit readiness across the QA team by serving as a technical resource on validation documentation standards and practices.
- Lead process improvement initiatives within the QA function, including automation framework adoption, testing efficiency improvements, and QA practice maturity.
- Guide and mentor more junior Software QA Testers on test design, automation framework usage, defect management practices, and Jira workflow.
- Evaluate and contribute practical improvements to the shared automation framework based on practical experience and support the broader team in applying it effectively.
- Participate actively in cross-functional process improvement discussions, representing the QA team’s technical perspective and contributing actionable improvements.
- Experience: 7–9 years of related experience, or 10+ years of related experience.
- Education: (Honours) Bachelor's degree, or an equivalent combination of education and experience may be considered.
- Language: Fluent in English (verbal and written).
- Solid working knowledge of regulated software testing frameworks, including CSV, CSA, GAMP5, ISO 62304, ISO 62366, and 21 CFR Part 11.
- Demonstrated experience owning test strategy and execution for complex software products with minimal supervision.
- Hands-on experience applying and extending automated test frameworks, with proficiency in Selenium, AccelQ, and similar platforms.
- Advanced proficiency with Jira for defect tracking, triage, and workflow management within Agile and Scrum environments.
- Experience with API testing tools such as Postman and JMeter.
- Experience producing and maintaining regulated validation documentation, including traceability matrices and test summary reports.
- Proficiency in SQL and MySQL for test data queries and validation support.
- Experience testing complex desktop and web-based applications, including React-based user interfaces and integrated system workflows.
- Strong written and verbal communication skills, with the ability to communicate quality risks effectively to both technical and non-technical audiences.
- Demonstrated ability to provide informal technical guidance and mentoring to less experienced team members.
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