Open to opportunities

Zhanna Tukin

@zhannatukin

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Experienced QA engineer specializing in medical device and IoT verification and validation.

United States

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What I'm looking for

I am seeking QA/validation roles where I can lead testing efforts, ensure regulatory compliance (FDA, ISO 13485, IEC 62304), mentor teams, and drive high-quality product releases in medical device or IoT domains.

I am an Information Technology professional with 8+ years of experience testing software, firmware, hardware, mobile applications and connected devices across medical devices, medical imaging, consumer electronics, IoT, e‑commerce, and automotive industries. I lead QA teams, mentor staff, and deliver high-quality results on schedule using IEEE-aligned V&V processes and strong regulatory expertise.

I have developed and executed test strategies, plans, manual test cases, and traceability matrices for FDA-, ISO 13485- and IEC 62304-compliant products, and I am proficient with tools such as Jira, Bugzilla, TeamCity and others. I bring a proactive, results-driven approach to cross-functional collaboration and risk-based testing to ensure product safety and clinical accuracy.

Experience

Work history, roles, and key accomplishments

Software Engineer

CriTech Research LLC

Jul 2021 - Jan 2025 (3 years 6 months)

Developed and executed IEEE-based V&V test plans and manual test cases for software and hardware medical devices, ensuring compliance with FDA, ISO 13485, and IEC 62304 and maintaining end-to-end QA documentation and traceability.

Test Planning FDA Compliance ISO 13485 EN 62304 Manual Testing Test Case Documentation

Software Test Engineer

INVIA Medical Solutions

Aug 2017 - Dec 2018 (1 year 4 months)

Designed and executed functional and regression test plans for cardiovascular imaging software, updated requirements for clinical accuracy, and ensured full requirements-to-test traceability while coordinating with clinical testers and developers.

Manual Testing Traceability Regression Testing Medical Imaging Clinical Validation

Tester

Nordicinox

Mar 2013 - Dec 2015 (2 years 9 months)

Performed GUI, functionality, compatibility, performance, usability, and localization testing for client websites and assisted with HTML-based development, reporting defects and coordinating remediation with development teams.

Performance Testing Usability Testing Localization HTML Cross Browser Testing

QA Lead

Fitbit Inc.

Apr 2009 - Mar 2013 (3 years 11 months)

Led a geographically distributed QA team of 6 for consumer IoT wearables, developed release test plans, tracked quality metrics, and coordinated GUI, functional, integration, system, usability, and regression testing to support product releases.