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I'm a detail-oriented and certified software quality testing professional (ASTQB) with approximately 4 years of hands-on experience in manual and automated testing across Biomedical Device Applications, Embedded Systems, and Blockchain. I design, execute, and manage test plans aligned with FDA (21 CFR Part 820) and ISO 13485 standards, ensuring product reliability and patient safety. I collaborate with cross-functional teams, perform firmware and cloud-based application testing, and leverage tools such as Jira, Jama, SmartSolve, Selenium, Python, and AWS to deliver secure, compliant solutions. A Six Sigma Green Belt, I bring a continuous improvement mindset to every project and strive for excellence in quality delivery and regulatory compliance.…I'm a detail-oriented and certified software quality testing professional (ASTQB) with approximately 4 years of hands-on experience in manual and automated testing across Biomedical Device Applications, Embedded Systems, and Blockchain. I design, execute, and manage test plans aligned with FDA (21 CFR Part 820) and ISO 13485 standards, ensuring product reliability and patient safety. I collaborate with cross-functional teams, perform firmware and cloud-based application testing, and leverage tools such as Jira, Jama, SmartSolve, Selenium, Python, and AWS to deliver secure, compliant solutions. A Six Sigma Green Belt, I bring a continuous improvement mindset to every project and strive for excellence in quality delivery and regulatory compliance.

Seema Narkhede

QA Engineer, Web Developer, Full Stack Developer, +2

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I'm a detail-oriented and certified software quality testing professional (ASTQB) with approximately 4 years of hands-on experience in manual and automated testing across Biomedical Device Applications, Embedded Systems, and Blockchain. I design, execute, and manage test plans aligned with FDA (21 CFR Part 820) and ISO 13485 standards, ensuring product reliability and patient safety. I collaborate with cross-functional teams, perform firmware and cloud-based application testing, and leverage tools such as Jira, Jama, SmartSolve, Selenium, Python, and AWS to deliver secure, compliant solutions. A Six Sigma Green Belt, I bring a continuous improvement mindset to every project and strive for excellence in quality delivery and regulatory compliance.…I'm a detail-oriented and certified software quality testing professional (ASTQB) with approximately 4 years of hands-on experience in manual and automated testing across Biomedical Device Applications, Embedded Systems, and Blockchain. I design, execute, and manage test plans aligned with FDA (21 CFR Part 820) and ISO 13485 standards, ensuring product reliability and patient safety. I collaborate with cross-functional teams, perform firmware and cloud-based application testing, and leverage tools such as Jira, Jama, SmartSolve, Selenium, Python, and AWS to deliver secure, compliant solutions. A Six Sigma Green Belt, I bring a continuous improvement mindset to every project and strive for excellence in quality delivery and regulatory compliance.

Available to hire

I’m a detail-oriented and certified software quality testing professional (ASTQB) with approximately 4 years of hands-on experience in manual and automated testing across Biomedical Device Applications, Embedded Systems, and Blockchain. I design, execute, and manage test plans aligned with FDA (21 CFR Part 820) and ISO 13485 standards, ensuring product reliability and patient safety.

I collaborate with cross-functional teams, perform firmware and cloud-based application testing, and leverage tools such as Jira, Jama, SmartSolve, Selenium, Python, and AWS to deliver secure, compliant solutions. A Six Sigma Green Belt, I bring a continuous improvement mindset to every project and strive for excellence in quality delivery and regulatory compliance.

Skills

Experience Level

Expert

Expert

Expert

Expert

Expert

Intermediate

Intermediate

Intermediate

Work Experience

QA Engineer at huMannity Medtec

June 1, 2024 - April 1, 2025

Verified system functionality against SRS documents, ensuring alignment with FDA and ISO 13485 compliance. Reviewed SRS to ensure consistency with project objectives. Logged and managed test items and test cases using Jira, Jama, SmartSolve, and SharePoint; created and maintained functional test cases and test plans within Jira and Jama. Reviewed and approved functional test cases for coverage and accuracy. Designed and executed test cases for defects and ad-hoc scenarios; collaborated with cross-functional and offshore teams to log and analyze defects and propose corrective actions via Jira. Participated in team meetings, led UAT, and executed automated test cases with documented results. Ensured adherence to organization-wide quality standards; updated checklists and documentation for continuous improvement. Performed dry-run and formal-run testing within Jama cycles; executed functional, regression, smoke, sanity, exploratory, and end-to-end tests. Conducted database, cloud, applica

QA Engineer at Crypto Asset Rating, NY

February 1, 2023 - September 1, 2023

Validated system development against SRS documents, reviewed requirements for completeness and accuracy. Designed and maintained functional test cases and test plans aligned with project requirements; reviewed and approved test cases for adequate coverage. Logged and tracked defects, collaborated with functional teams to analyze root causes and suggest corrective actions. Executed manual functional tests, documented results for QA sign-off, and participated in UAT. Ensured compliance with QA standards and maintained QA checklists. Performed front-end and back-end validation using PL/SQL for data consistency and integrity. Initiated automation learning with Python and Selenium for future test development.

QA Engineer at Cube Root Software, Pune

June 1, 2016 - April 1, 2018

Analyzed customer requirements and translated them into detailed functional test cases. Executed manual test cases following SDLC methodologies to validate product functionality. Logged and tracked defects with clear reproduction steps and verified fixes. Performed white-box and black-box testing to ensure comprehensive coverage. Prepared and shared bug-tracking reports to support QA efforts.

QA Instructor at Sutra Infotech, Thane

September 1, 2010 - November 1, 2011

Mentored 50+ students on foundational manual testing concepts and SDLC models.