Medical Devices Regulatory Compliance

Joseph Childree

Windsor, CO *****

970-***-**** ***********@*****.*** www.linkedin.com/in/joseph-childree QA Software Tester – Medical Devices

Results-driven Senior Validation Engineer with 9+ years of experience ensuring software and systems meet regulatory compliance and quality standards — including FDA 21 CFR Part 11, 820, ISO 13485, and IEC 62304. Proven success in manual and automated testing, defect tracking, and risk management across medical devices and diagnostic systems.

Key Skills and Expertise

Test Planning & Design: Develop and execute detailed Test Plans and Test Cases based on regulatory guidelines and system requirements.

Regulatory Compliance: Deep knowledge of medical device regulations and SDLC standards. Ensure QMS documentation meets FDA and ISO compliance requirements. Defect Identification & Management: Skilled in defect tracking tools (JIRA, Spirateam), root cause analysis, and collaborating with development teams for issue resolution. Automation & Performance Testing: Proficient in TestComplete, Visual Studio, Python, and Selenium to automate test scenarios and improve efficiency. Validation & Verification (V&V): Extensive experience in functional testing, integration testing, system testing, and user acceptance testing (UAT) for medical devices. Cross-functional Collaboration: Work seamlessly with cross-disciplinary teams — from developers to quality and regulatory teams — ensuring product reliability and timely delivery. Professional Experience

IQVIA – Durham, NC Senior Validation Engineer

December 2018 – January 2025

Led validation efforts for 80+ client projects (Johnson & Johnson, Novartis, AstraZeneca), ensuring full compliance with FDA and ISO 13485 standards.

Developed comprehensive test plans and traceability matrices, ensuring all testing phases met regulatory and QMS requirements.

Automated testing scenarios to improve efficiency, reducing manual testing time while maintaining accuracy.

Mentored and trained 6 junior engineers to improve team performance and ensure consistent validation processes.

ERT iCardiac nSpire Health – Longmont, CO Validation Associate June 2016 – October 2018

Performed simulation and debugging of software for respiratory and ECG medical devices, ensuring reliability and regulatory compliance.

Automated complex test processes with TestComplete and Visual Studio, enhancing test efficiency and accuracy.

Identified performance bottlenecks and optimized validation strategies, improving throughput and reliability.

Acclimated to three seperate cultures successfully, through two seperate company acquisitions within the same role.

Military Experience

US Navy – Lemoore, CA Aviation Electrician (E-5) September 2006 – September 2011

Led maintenance and quality assurance for 12 multimillion-dollar aircraft avionics systems, adhering to DO-178C standards.

Trained personnel in diagnostics, troubleshooting, and compliance inspections. Commendations include Good Conduct Award and Letters of Accommodation. Education

Bachelor’s Degree – Computer Information Systems

DeVry University – Westminster, CO

Technical Skills

Programming: C/C++, C#, JAVA, Python, Perl

Tools: TestComplete, Visual Studio, JIRA, Spirateam Automation & Scripting: Python, PERL, Selenium

Defect Tracking & Reporting

Performance Testing & Optimization

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