Software Quality Engineer - V&V

Software Quality Engineer – V&V

Bachelor’s degree (BS/BA) in Information Technology, Computer Science, Engineering, or a related field.
1–3 years of hands-on software testing experience.
Working knowledge of the Software Development Life Cycle (SDLC).
Experience with test management systems, bug tracking tools, and documentation platforms.
Strong attention to detail, time management, and ability to work independently under pressure.
Excellent communication skills in English (verbal and written).

Plan, design, and execute functional, integration, and regression test cases for clinical software products.
Review system specifications, requirements, and user manuals for testability and completeness.
Collaborate with internal stakeholders (developers, project managers, and study teams) to understand software changes and define test strategies.
Identify, document, and track software defects through resolution using established bug tracking systems.
Ensure traceability between test cases and requirements for audit readiness.
Prepare and maintain comprehensive test documentation aligned with regulatory and internal SOP requirements.
Set up and maintain test environments, tools, and test data for assigned projects.
Contribute to continuous improvement by identifying testing process gaps and proposing enhancements.
Manage multiple testing projects, monitor timelines, and escalate risks or roadblocks to leadership.
Provide accurate test effort estimations and project status reporting to stakeholders.
Mentor junior team members and participate in cross-functional training and collaboration.
Participate in audits, customer calls, UATs, and root cause analysis sessions as needed.

Exposure to test automation, Agile methodologies, and regulated environments (e.g., GCP, FDA, EMA) is a plus.
ISTQB Foundation Level certification is a plus.
Previous experience working with clinical software or medical devices preferred.
Intermediate experience with Clario software/hardware is a plus.