Sr.qa Engineer Resume
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Atlanta, GA
SUMMARY:
- Technical Lead in Verification& Validation in Confidential Inc.
- 12 years of experience in the field of Software Testing Manual with Automation .
- 8 years of core verification experience in Medical Device product in adherence to FDA 510k processes (Class I and Class II Medical Device). Good familiarity with the FDA.
- Expertise in designing comprehensive test plans, test reports, test workflows, scenarios and test cases. Writing automated function and system tests. Experience with Agile and Waterfall software development methodologies.
- Participating in component design reviews, experience in software system validation witin a GXP environment.
- Development experience in C++ .
- Automated test development and test tool development.
- Design & develop of the test protocols and Experience with test simulator
- Execute test plans and write reports to meet design control standards
- Ability to give direction as project lead and execute tasks consistently
- In - depth knowledge of analyzing and resolving complex scenarios and defects under Agile Software Environment. Reporting bugs and verifying fixes.
- Experience in Software Testing Life Cycle, Test Strategy and Test planning, black box testing.
- Excellent communication skills
PROFESSIONAL EXPERIENCE:
Sr.QA Engineer
Confidential, Atlanta GA
Responsibilities:
- Performed various tests which include validation and verification of software for the Freestyle EMQ.
- Test Automation script development in Python
- Worked in Scrum/Agile testing methodologies.
- Test Framework development in Python
- Test strategy and Test Design planning and implementation
- Iterative development
- Requirement Analysis
Tools: Python 3, Pycharm, Eclipse IDE, TFS, Test Manger, JIRA.
Sr.V&V Engineer
Confidential, Boston, MA
Responsibilities:
- Involved in verification and validation of the MVAD system.
- Automated test framework in Python and Communication protocol simulator for system verification
- Performed System/Software Verification and Validation activities for medical device products.
- Create and execute test method validations and design verification protocols and reports
- Designed, developed, dry-ran and formally executed efficient and effective test protocols to ensure delivery of quality products within cost and on schedule, and in compliance with all FDA/QSR/ISO and corporate standards/guidelines. Provided requirements traceability throughout software product development.
- Capture and present test data for analysis by Subject Matter Experts (SMEs)
- Mentoring of intern, young and inexperienced engineers.
- Estimated, planned and scheduled system/software verification and validation tasks to ensure timely delivery of quality and customer-specific products.
Tools: Python 2.7, Eclipse IDE, Test Track, Oscilloscope, Yokogawa, Power simulator and battery communication simulator.
Sr. V&V at Haemonetics
Confidential
Responsibilities:
- Write test cases and other documents for the validation of tools and test fixtures.
- Protocol development for surgical products to meet customer specific requirement.
- Developed and Maintain traceability from requirements and design elements to corresponding verification activities
- Coordinate system verification activities across functional areas
- Participate in cross-functional design reviews
- Provides written reports, protocols and Prepares progress reports on projects as required
- Defect logging and tracking using IBM RQM/RTC and PVCS Tools
- Develop/Execute/Review Test cases as per the Requirement Specifications identified for the device
Tools: Rational DOORs, RQM and RTC, PVCS defect tracking tool.
V&V engineer
Confidential
Responsibilities:
- Perform System Testing, Functional testing through executing Test Cases and Ad-Hoc Testing
- Computer System Validation procedure, for the Embedded Downloader software and Verification of Glucose Engine Simulator including checking of application code and application updates via IR
- Unit Testing for EAW by using AWEventTest.dsp Script
- Reporting of bugs in intermediate releases of the application
- Communicating the defect data with the development team.
- Logging defects in defect tracker tool and Verifying the reported defects
Tools: Quality Center, CGM (Continuous Glucose Monitor), ezManager
V&V engineer
Confidential
Responsibilities:
- Perform System and Integration testing through executing test cases and ad-hoc testing
- Regression testing
- Testing on Multiple Platforms (32 and 64 bits)
- Logging the defects and Interacting with the development team on various forums to clarify any queries regarding the functionality
- Logging the defects in defect tracker tool and coordinating with the development team
Confidential
Responsibilities:
- Coding in C++, Bug Fixing and Testing
- Communication with the Test Lead / Test Manager
- Conducting Review Meetings within the Team
Confidential
Responsibilities:
- Implement the requirement and develop the application in .Net technology
- Performed unit testing