•Responsible for Quality control and Quality assurance operations at Benetech Inc.•Experience with ISO13485, ISO14971,MDSAP,Software as a Medical Device (SaMD), CE Marking,GTIN-12.•Developed,Implemented and Managed the Quality assurance program related to medical device activities.•Experience in writing Standard Operating Procedures required to meet the quality objectives.•Worked on improvement of Quality management System for MDSAP Audit.•Prepared Technical Documentation… Show more •Responsible for Quality control and Quality assurance operations at Benetech Inc.•Experience with ISO13485, ISO14971,MDSAP,Software as a Medical Device (SaMD), CE Marking,GTIN-12.•Developed,Implemented and Managed the Quality assurance program related to medical device activities.•Experience in writing Standard Operating Procedures required to meet the quality objectives.•Worked on improvement of Quality management System for MDSAP Audit.•Prepared Technical Documentation for New CE Mark and revised current Standard operating Procedures in order to comply with Changes.•Worked on preparing Quality Plan for shift of Designated body in Europe i.e UL to PCBC.•Working on FMEA Risk analysis Documentation and applying Risk Based Approach during Development.•Performed Management Review Meetings and presented the outcome to Team Members.•Performed Gap Analysis of ISP 13485:2016 and applied changes in Benetech's Quality Management System Show less

•Identify, define and write test cases and scenarios based on the business requirements.•Create and execute comprehensible, repeatable, and measurable regression test suites for existing functionality in the PRA backend applications.•Develop test strategies, formal test plans, automation scripts (API/UI level scripts), and system configurations to efficiently validate compliance to product design requirements and design guidelines and development plans.•Identify and prioritize tests… Show more •Identify, define and write test cases and scenarios based on the business requirements.•Create and execute comprehensible, repeatable, and measurable regression test suites for existing functionality in the PRA backend applications.•Develop test strategies, formal test plans, automation scripts (API/UI level scripts), and system configurations to efficiently validate compliance to product design requirements and design guidelines and development plans.•Identify and prioritize tests that are candidates for automation.•Assist in review of the business requirements and the implemented solution, and identify gaps/conflicts with the existing system.•Log defects and work closely with developers and the operations team to investigate, troubleshoot and verify defect fixes.•Strong experience in test Automation tools:Selenium,HP UFT and Appium Show less

•Responsible for understanding and analyzing the Business Requirements, part of the team for developing Test Script, Test Scenario and Test Cases (designing and reviewing), prepared and executed Test Data and following the Agile methodology•Involved in the creation, design, and format of Requirement Traceability document•Developed test cases and automation scripts for the core application and new features and ensured defect free release of the application•Developed test scripts… Show more •Responsible for understanding and analyzing the Business Requirements, part of the team for developing Test Script, Test Scenario and Test Cases (designing and reviewing), prepared and executed Test Data and following the Agile methodology•Involved in the creation, design, and format of Requirement Traceability document•Developed test cases and automation scripts for the core application and new features and ensured defect free release of the application•Developed test scripts using Selenium WebDriver with Java and TestNG framework and SOAPUI based test cases for Webservices (API) based testing•Performed test suite on iPhone and Android, executed planned tests for Android, Windows, and Mac OS•Responsible for reporting the bugs in JIRA and tracking them till closure•Performed E2E testing, functional and regression testing in various browsers like, Safari and Google Chrome •Performed Functional, Compatibility, and Regression testing across various environments using test scripts•Executed compatibility testing, using different mobile devices and Android SDK•Performed Mobile Functional Testing on real devices (Android, IOS and Windows Phone and Tablets), Simulators and Emulators •Opened and prioritized defect using JIRA, created detailed defect ticket including summary, defect module, platform and environment, steps to reproduce, and screenshot or video Show less