Open to opportunities

Irina Aksionkina

@irinaaksionkina

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I lead quality and compliance in regulated healthcare SaaS, owning CSV, IQ/OQ/PQ, and release go/no-go decisions.

United States

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What I'm looking for

I’m looking for a regulated-healthcare SaaS role where I can own quality end-to-end—CSV/IQ/OQ/PQ, test strategy, and release decisions—while continuously improving compliance and automation with my AI-assisted testing mindset.

I got into QA because I care about whether software actually works—not just whether it passes a test. Eight years later, that instinct is what I bring to every release cycle, validation protocol, and go/no-go decision in regulated healthcare environments.

I’m genuinely comfortable across the full QA spectrum: hands-on exploratory testing, building and executing automated regression suites, writing IQ/OQ/PQ validation protocols, and making the final call on a release. My specialty is where quality meets compliance—Computer System Validation (CSV), GxP, and 21 CFR Part 11—where I don’t just execute processes, I own them.

In my most recent role, I held Validation Lead responsibilities with sign-off authority on major platform releases. I drove end-to-end CSV lifecycle execution (IQ, OQ, PQ), maintained audit-ready documentation, and helped sustain outcomes including zero audit findings, zero release delays, and 100% release cadence across two regulated product lines.

I also build out of curiosity, including QA Pilot, my personal AI project that auto-generates BDD/Gherkin test cases from Jira user stories and writes them back as Xray test issues. I’ve applied AI-assisted testing in practice using TestCraft and Claude/Anthropic Claude to expand edge-case coverage and improve release confidence.

Experience

Work history, roles, and key accomplishments

Senior Quality Assurance Engineer

Hawthorne Health, Inc.

Sep 2021 - Jun 2026 (4 years 9 months)

Projects: VDP — Data Tracking System for Clinical Trials | Participant Recruitment Engine
• Validation Lead responsibilities · 2025–2026
• Held go/no-go sign-off authority on all major platform releases — reviewing and approving test execution reports, co-authoring IQ/OQ/PQ validation protocols, and confirming GxP and 21 CFR Part 11 compliance before every release.
• Sustained zero audit findings

Quality Assurance Engineer

Akerna

Mar 2020 - Sep 2021 (1 year 6 months)

Company later rebranded to Gryphon Digital Mining
Project: MJFreeway
• Engineered automated test cases in Katalon Studio using Gherkin/BDD, expanding regression suite coverage and measurably reducing manual test execution time for every new feature release.
• Executed multi-layered test campaigns — smoke, functional, performance, and regression — across automated and manual tracks simultaneously,

Test Execution Katalon Studio Groovy Exploratory testing Test Automation Gherkin Cucumber

QA Engineer

Coherent Solutions

May 2018 - Feb 2020 (1 year 9 months)

Project: MJFreeway
• Delivered validated tickets daily through exploratory, API (REST/Postman), and regression testing — consistently exceeding throughput benchmarks without sacrificing quality standards.
• Engineered Xray test cases for new features and validated outcomes against requirements, providing structured developer-ready defect feedback that accelerated fix cycles.
• Partnered proactivel

Regression Testing SQL Jira Test Execution Test Cases End To End Testing API Testing Zephyr Scrum Agile Testing Documentation

Education

Degrees, certifications, and relevant coursework

Bellevue College

Software Test Engineer Certificate Program

2011 - 2013

Completed a 199-hour professional certificate program in
software test engineering — one of the most comprehensive
QA training programs in the Pacific Northwest. Covered
the full testing lifecycle from test planning and execution
to defect reporting, automation fundamentals, and building
a professional QA portfolio.