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I am a Software Quality Engineering Manager with 15+ years of experience leading functional and automation QA initiatives within regulated SaaS environments supporting pharmaceutical, biotech, and clinical trial platforms. I thrive on building scalable regression and validation strategies across UI, API, and backend systems, and I’m passionate about delivering release-ready quality in Agile, regulated settings. I’ve guided cross-functional QA teams, partnered with Product and Engineering to prioritize testing scope, and worked closely with Customer Support to triage production issues. I maintain audit-ready documentation aligned with FDA and ISO standards, and I am proficient with Linux-based environments, leveraging Jira, Xray, Confluence, Azure DevOps, GitHub, and CI/CD tooling to drive quality.…I am a Software Quality Engineering Manager with 15+ years of experience leading functional and automation QA initiatives within regulated SaaS environments supporting pharmaceutical, biotech, and clinical trial platforms. I thrive on building scalable regression and validation strategies across UI, API, and backend systems, and I’m passionate about delivering release-ready quality in Agile, regulated settings. I’ve guided cross-functional QA teams, partnered with Product and Engineering to prioritize testing scope, and worked closely with Customer Support to triage production issues. I maintain audit-ready documentation aligned with FDA and ISO standards, and I am proficient with Linux-based environments, leveraging Jira, Xray, Confluence, Azure DevOps, GitHub, and CI/CD tooling to drive quality.

David Quan Lam

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I am a Software Quality Engineering Manager with 15+ years of experience leading functional and automation QA initiatives within regulated SaaS environments supporting pharmaceutical, biotech, and clinical trial platforms. I thrive on building scalable regression and validation strategies across UI, API, and backend systems, and I’m passionate about delivering release-ready quality in Agile, regulated settings. I’ve guided cross-functional QA teams, partnered with Product and Engineering to prioritize testing scope, and worked closely with Customer Support to triage production issues. I maintain audit-ready documentation aligned with FDA and ISO standards, and I am proficient with Linux-based environments, leveraging Jira, Xray, Confluence, Azure DevOps, GitHub, and CI/CD tooling to drive quality.…I am a Software Quality Engineering Manager with 15+ years of experience leading functional and automation QA initiatives within regulated SaaS environments supporting pharmaceutical, biotech, and clinical trial platforms. I thrive on building scalable regression and validation strategies across UI, API, and backend systems, and I’m passionate about delivering release-ready quality in Agile, regulated settings. I’ve guided cross-functional QA teams, partnered with Product and Engineering to prioritize testing scope, and worked closely with Customer Support to triage production issues. I maintain audit-ready documentation aligned with FDA and ISO standards, and I am proficient with Linux-based environments, leveraging Jira, Xray, Confluence, Azure DevOps, GitHub, and CI/CD tooling to drive quality.

Available to hire

I am a Software Quality Engineering Manager with 15+ years of experience leading functional and automation QA initiatives within regulated SaaS environments supporting pharmaceutical, biotech, and clinical trial platforms. I thrive on building scalable regression and validation strategies across UI, API, and backend systems, and I’m passionate about delivering release-ready quality in Agile, regulated settings.

I’ve guided cross-functional QA teams, partnered with Product and Engineering to prioritize testing scope, and worked closely with Customer Support to triage production issues. I maintain audit-ready documentation aligned with FDA and ISO standards, and I am proficient with Linux-based environments, leveraging Jira, Xray, Confluence, Azure DevOps, GitHub, and CI/CD tooling to drive quality.

Skills

Experience Level

Expert

Expert

Expert

Expert

Expert

Expert

Intermediate

Intermediate

Language

English

Fluent

Work Experience

Manager, Quality Engineering at Endpoint Clinical

January 1, 2020 - January 1, 2024

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.

Test Lead, Product Testing and Technical Delivery at Signant Health Global

January 1, 2014 - January 1, 2020

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.

Software Test Engineer I/II/III at Signant Health Global

January 1, 2010 - January 1, 2014

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.