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Thomas Barrett

@thomasbarrett

Senior QA Consultant at IonSQA who developed an agentic AI tool that cut XML validation time to production by 70%.

At IonSQA, I lead AI governance, clinical software QA, and data integrity consulting for biotech, pharma, and healthcare clients. My work includes regulatory gap analysis and AI-informed validation to support FDA, GxP, and ISO 13485 compliance.

At IMAT Solutions, I led QA review and validation of clinical data pipelines across CCD, FHIR, flat-file, and HL7 formats. I also developed a Python-based automation tool using agentic AI in VS Code to validate XML structures and tags, reducing time to production promotion by 70%.

At Ilum Health Solutions / Infectious Disease Connect, I built and managed the QA department supporting healthcare platforms across web, mobile, and back-end systems. I also performed clinical validation of an AI-powered machine-learning antibiogram, including checks of real-time data ingestion and predictive accuracy.

Earlier, I led QA and validation work across government, healthcare, finance, and software projects, including independent validation for New York State of Health and a Medicaid database migration from IBM Mainframe DB2 to MS SQL. I bring experience in system validation, clinical data quality, regulatory compliance, and AI-supported testing.

Experience

Work history, roles, and key accomplishments

Current

Senior QA Consultant

Current

IonSQA

Mar 2026 - Present (7 months)

Leading AI governance, clinical software QA, and data integrity consulting for biotech, pharma, and healthcare clients. Ensuring FDA, GxP, and ISO 13485 compliance through audits, QMS reviews, and regulatory gap analysis.

AI Governance Clinical QA Data Integrity FDA Compliance GxP ISO 13485 Audit QMS Regulatory Gap Analysis IQ OQ PQ Validation HITRUST SOC2 HIPAA Test Planning Defect Reporting Regression Testing

Senior QA Lead – Clinical Data Validation

IMAT Solutions

Mar 2023 - Feb 2026 (2 years 11 months)

Led a team of five data analysts in a matrix organization for the Aurora Advocate Health CMS project. Extensive use of MySQL for validation of large data sets across dozens of EHRs and verifying data pipes.

MySQL MariaDB Data Validation Electronic Health Records (EHR)CCD FHIR HL7 Python VSCode Data Wrangler Agentic AI XML ETL Query Optimization AI driven Analytics Mentorship

QA Manager

Ilum Health Solutions / Infectious Disease Connect

Dec 2018 - Dec 2022 (4 years)

Built and managed the QA department supporting multiple SaaS healthcare platforms. Performed QA and clinical validation for an AI-powered, machine-learning antibiogram, verifying real-time data ingestion and predictive accuracy.

Pl SQL PgAdmin API Testing UI Testing Regression Testing AI Assisted Test Generation Defect identification Defect Tracking Root Cause Analysis Agile Waterfall Performance Testing Security Penetration Testing

QA Manager / Configuration Manager

NFRASTRUCTURE

Apr 2018 - Nov 2018 (7 months)

Led QA in a matrix organization for SUNY Research Foundation projects, running release cycles and administering HP ALM suite. Standardized QA processes, reporting structures, and test documentation.

HPALM QA Processes Configuration Management Oracle System Testing Performance Testing Test Planning Defect Reporting Regression Testing

IV&V QA Test Lead

IES-NEW YORK STATE OF HEALTH (NYSOH)

Jul 2016 - Feb 2018 (1 year 7 months)

Led QA operations for Medicaid and state insurance marketplace systems under IV&V contract requirements. Managed functional testing, regression validation, defect triage, and automation oversight.

IV&V Medicaid Case Management Functional Testing Regression Testing Defect Triage Automation Performance Testing Security Testing Technical Reviews

QA Manager

CMA

Apr 2016 - Jul 2016 (3 months)

Led IBM Mainframe DB2 database migration to MS SQL on Windows Server for State of NJ Medicaid program. Led daily stand-up for data migration team and co-managed upgrade QA team.

IBM Mainframe DB2 MSSQL Windows Server Data Migration Test Planning Defect Reporting Regression Testing

QA Team Lead

Xerox Corporation

Jan 2013 - Apr 2016 (3 years 3 months)

QA Test lead of local and offshore test teams for web-based software testing, failure analysis, and defect tracking. Led local and offshore work groups for 24-hour testing coverage.

HPALM Selenium JavaScript Oracle Data Validation Performance Testing Test Planning Defect Tracking Regression Testing UNIX Shell Scripting

QA Manager

Pearl Carroll Insurance

Jul 2012 - Dec 2012 (5 months)

QA manager responsible for SDLC process development, TFS administration, software testing, and performance testing.

SDLC TFS Software Testing Performance Testing

QA Lead

GE Intelligent Platforms

Jan 2008 - Jul 2012 (4 years 6 months)

Led a team of validation engineers in the automated robotics project. Created Jira dashboards and reports from scratch for project tracking and QA reporting.

Jira Green Hopper Python JavaScript VSCode Robotics Testing Automation Agile Scrum Test Planning Performance Testing

QA Lead

Bank of America

Jul 2007 - Dec 2007 (5 months)

Led a five-person QA team for NY State Tax and Finance image scanning verification. Performed data validation for image capture system upgrades and system testing from tax form capture.

Data Validation Photo Capture System Testing Throughput Validation Output Verification Team Leadership

SQA Engineer

Autotask

Jul 2005 - Jul 2007 (2 years)

Performed requirements review, writing and executing test plans, test results reporting, troubleshooting, and automated test software implementation. Managed release management and process improvement.

Requirements Review Test Planning Test Execution Test Reporting Troubleshooting Testing Automation Release Management Regression Testing

Independent Software QA Consultant

Self Employed

May 2001 - Jul 2005 (4 years 2 months)

Consulted on software QA projects of all sizes from start-ups through large corporations, including data validation, systems engineering, process validation, and release management.

Data Validation Systems Engineering Process Validation Requirements QA Training Regression Testing Testing Automation Release Management

Software QA Lead/Software Systems Architect

COMSOLV

Jun 1999 - May 2001 (1 year 11 months)

Wrote and executed complex system testing, designed Active Directory database, and contributed to software systems architecture. Managed process creation and improvement.

System Testing Active Directory Database Design Software Architecture Test Planning Defect Reporting Regression Testing

Systems quality and compliance officer

Dura Pharmaceuticals

Apr 1998 - Jun 1999 (1 year 2 months)

Oversaw pharma IT systems validation and compliance, including Oracle DB administration and GxP validation per 21 CFR Part 11.

Pharma IT Systems Validation Oracle DB GxP 21 CFR Part 11 Compliance

Software QA Engineer

Newgen Results

Jul 1995 - Apr 1998 (2 years 9 months)

Performed test creation, review, and execution, UNIX shell integration testing, and established QA methods and processes. Conducted SQL data validation and regression testing.

Test Creation Test Execution UNIX Shell Scripting Integration Testing QA Processes SQL Data Validation Regression Testing