Senior Software QA Engineer with FDA Compliance Expertise

VLADIMIR FANDUNYAN

********@*******.*** 603-***-****

PROFESSIONAL SUMMARY

Experienced Software QA Engineer with over 10 years of hands-on expertise in manual and automated testing, focusing on critical industries like medical devices and enterprise software. Skilled in FDA compliance, software validation, and improving product reliability. Proficient in tools such as Selenium, Jira, Silk Performer, and LabView, with a strong ability to identify and resolve issues efficiently. Known for mentoring teams, working collaboratively, and delivering results under tight deadlines. Fluent in Armenian, Russian and Ukrainian, with a strong aptitude for adapting to new technologies and processes.

SKILLS

• Functional and security testing

• Software development lifecycle expertise

• Agile methodology and Scrum framework experience

• Strong communication and collaboration skills

• Test planning and execution

• FDA compliance knowledge

• Critical thinking and problem-solving

• Quadrilingual: English, Armenian, Ukrainian, and Russian EXPERIENCE

Software Quality Assurance Engineer

Sealbid Pro February 2021–June 2025

• Developed and executed detailed test plans to ensure software functionality.

• Performed manual testing to identify and document software defects effectively.

• Deployed new builds to test environments weekly, verifying seamless integration.

• Worked closely with developers to resolve issues and ensure stability.

• Conducted post-production testing to validate deployments. Software Quality Assurance Engineer

Philips Medical March 2015 – December 2021

• Validated 3D ultrasound systems, ensuring adherence to FDA regulations.

• Created and maintained test procedures for both new and legacy products.

• Collaborated with product teams to align testing with project objectives.

• Received recognition for identifying critical software issues, contributing to improved product quality.

Software Quality Assurance Engineer

Sunrise Labs-Medical Devices November 2011 – January 2015

• Created and executed manual and session-based test cases, utilizing Selenium for automation.

• Performed smoke, functional, regression, stress, and load testing to ensure software reliability.

• Documented software defects and enhancements in Trac, ensuring transparent communication with stakeholders.

• Regularly reviewed and updated existing test plans to reflect evolving requirements and industry standards.

Software Quality Assurance Engineer

Analogic Corporation March 2006 – September 2011

• Created and executed manual test cases for medical device software, adhering to regulatory standards.

• Tested new software builds on Vigileo, Vigilance, and LifeGuard devices, ensuring functionality.

• Verified junior team members' test results, ensuring accuracy.

• Streamlined bug tracking and resolution processes using PVCS.

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