Software QA Engineer

Dennis Zasoba

*********.******@*****.*** https://www.linkedin.com/in/dennis-zasoba-15481b59 San Jose, CA

Senior Quality Assurance Test Engineer

A dynamic and results-driven Software/System Test Engineer with over 12 years of experience in FDA-regulated environments. I specialize in Quality Assurance (QA) and have a passion for improving software applications, tools, robots, and instruments that aid in patients recovery time and potentially save lives. With my experience leading with internal and offshore teams, I excel in cross-functional collaboration while focusing on quality aligned with industry standards such as GCP, Part 11, ISO, IEC, GAMP5.

PROFESSIONAL EXPERIENCE

INDEPENDENT CONTRACTOR 2022 – NOW

MEDICAL PRODUCT SW/SYSTEM VERIFICATION ENGINEER at Albin Engineering

•Assisted in execution for V&V Phase towards FIH (First In Human) FDA submission for product in the field of cardiovascular interventions on the System level.

SOFTWARE QA ENGINEER at Neptune Medical

•Assisting with preparation for V&V Phase towards FDA submission of flexible endoscopy medical device in the field of Robotics.

•Creation and execution of test cases via Matrix Req application and Airtable to verify software design requirements.

SOFTWARE TEST ENGINEER at Johnson & Johnson

•Participated in Verification of software applications for a medical devices in the field of Robotics.

•Ensured software design and functional requirements were met, performing test cases execution and reporting bugs.

•Leveraged expertise in software, firmware, and hardware testing for complex electro-mechanical systems, troubleshooting subsystem integration issues, providing support for hardware updates/upgrades, and editing and executing Python.

SOFTWARE TEST ENGINEER at Seer Inc

•Verification and Validation of software applications for a medical devices in the field of Proteomics.

•Assisted SQA verification and validation activities to ensure software quality and performance up to industry standards.

FULL TIME POSITIONS

SENIOR SOFTWARE QUALITY ASSURANCE ENGINEER South San Francisco, CA 2021 – 2022

At Standard BioTools Corporation (Former Fluidigm)

•Led and executed SQA verification and validation activities for desktop medical device applications in the field of Genomics, ensuring system quality, functionality, and compliance with industry standards ( ISO-13485, ISO-14971, IEC-62603).

SOFTWARE VERIFICATION & VALIDATION ENGINEER at CORIN GROUP Santa Clara, CA 2019 – 2020

•Participated in Verification and Validation of desktop application for a robot-assisted medical device system in field of total joint replacement.

COMPREHEND SYSTEMS INC Redwood City, CA 2014 – 2019

SENIOR COMPLIANCE LEADER

Recognized and assessed compliance risks, auditing elements of the SaaS compliance program, and implemented corrective action plans to ensure adherence to regulatory standards.

SENIOR QA ENGINEER

Responsible for directing the successful completion for the software release validation processes.

Wrote detailed test plans, scenarios, ruby on rails script and procedures.

QA TEST ENGINEER

Tracked, logged, verified, and regressed software errors using GitHub and Target Processes.

Created test cases, test suites, test plans, and release notes matrices for software validation process.

QA ENGINEER/ANALYST Disney Interactive, Palo Alto, CA 2013 – 2014

Developed/executed test cases for testing a massive multiplayer online gaming application in Agile environment.

EDUCATION & PROFESSIONAL DEVELOPMENT

Mission College GED, Business/Corporate Communications

Portnov Computer School, Software Quality Assurance and Information Technologies

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