David Quan Lam

Led a team of 20 manual and automation QA engineers delivering sprint-based SaaS releases in regulated clinical software. Owned test planning, feature validation, regression execution, defect triage, and release readiness. Expanded UI, API, integration, and regression coverage across multiple product releases and validation cycles. Collaborated on automation roadmap, achieving a 25% efficiency gains via CI/CD-integrated automation. Partnered with Product and Development during sprint planning to define scope and risk, and produced QA metrics and release-readiness reports. Worked with Customer Support and Engineering to triage production issues and drive resolution. Ensured audit-ready validation documentation aligned with FDA 21 CFR Part 11 and ISO standards. Supported Linux environments and used Jira, Xray, Confluence, Azure DevOps, GitHub, and CI/CD tooling.

Led Functional QA across web, mobile, API, and backend systems for enterprise SaaS clinical trial platforms. Coordinated sprint-level testing, UAT support, and defect management across Agile teams. Built scalable regression and traceability using Jira/Xray, improving testing visibility and readiness by 90%. Developed SQL-driven backend validation tests and API-focused testing strategies to ensure data integrity. Collaborated with Product Management and Development to support release readiness and risk assessment. Provided mentorship on testing methodologies and validated processes, reducing recurring issues. Worked in Linux/Unix environments and leveraged Jira, Confluence and automation tooling to support release engineering.

Executed manual test cases and validation protocols for clinical and medical software systems. Performed system and integration testing for IxRS platforms, improving system reliability. Authored and maintained test plans, test cases, and validation documentation in regulatory compliance. Supported multiple product releases with <1% escaped defects through thorough testing and defect tracking.