Madhan Kumar R

• Analyzed system requirements and defined testing specifications, creating Validation plan, Design Specifications, test plans and test scripts for comprehensive testing coverage. • Acted as the liaison between business stakeholders and development team to gather requirements and Product Improvements. • Worked in an Agile/Scrum environment, using Jira to manage sprint backlogs, user stories, and development tasks. • Designed and executed functional, end-to-end testing, and regression testing. • Thrive in a fast-paced environment by effectively navigating ambiguity and adapting to evolving needs driven by senior leadership requests. • Own and maintain the product backlog, ensuring it is prioritized based on business goals, customer value, and regulatory compliance (e.g., FDA, ISO standards). • Collaborate with stakeholders (customers, users, R&D, UX/UI, quality assurance, regulatory) to gather, define, and document product requirements.

• Created Software Requirements Specifications (SRS) and Functional Design Documents for DTRAK and ServiceNow CMF. • Coordinated with teams (mSTAR, Carelink, Mendix PEMS, ServiceNow, GCH) to ensure 100% accurate device and patient data flow across systems and verify the functionality of ServiceNow applications like CMF and Get Connected • Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. • Good experience in implementing FDA's 21 CFR Part 820 requirements for medical device manufacturers, including design controls, document controls, CAPA, and record-keeping.

• Analyzed and developed a large-scale data conversion project documentation, ensuring successful transfer into Hadoop System. • Designed and executed testing frameworks, reducing the time required for regression testing. • Conducted risk assessments to identify potential system issues before deployment. • Clearly communicated testing results and risks to stakeholders, improving decision-making. • Improved software release cycles by implementing best practices in continuous integration and delivery (CI/CD). • Participated in daily stand-up meetings, ensuring project timelines stayed on track.

• Led analysis of business, system, and data mapping requirements, collaborating with clients, developers, and QA teams to define and execute comprehensive test plans for functional, regression, UAT, and stress testing • Led Web Application and Web Services testing with SoapUI/ReadyAPI and Selenium, leveraging Oracle/SQL for backend validation and ensuring seamless integration. • Created comprehensive test reports including BAT, helping teams track testing results and plan improvements. • Managed defect tracking in JIRA, keeping stakeholders informed of testing progress. • Worked closely with Scrum teams and been part of daily stand-up meetings.

• Created and managed comprehensive testing documentation, including test strategies, plans, cases, and defect reports, ensuring accuracy and smooth collaboration across teams • Led Agile development efforts by implementing and supporting new tools (TMAP, Agile), conducting demos, and guiding teams through smooth adoption to enhance collaboration and efficiency • Led defect tracking and user acceptance testing (UAT) while providing guidance on functional and performance test development using the Open-load tool, ensuring thorough test coverage and optimized system performance • Developed detailed test reports and comprehensive documentation, ensuring clear project tracking and efficient communication throughout the testing process. • Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. • Good experience in implementing FDA's 21 CFR Part 820 requirements for medical device manufacturers, including design controls, document controls, CAPA, and record-keeping.

• Analyzed requirements, created the Master Test Plan, and developed estimates and resource plans to ensure the project met deadlines set by the project managers. • Designed and developed both front-end and back-end test scenarios, performing Functional Testing, Performance Testing, Integration Testing, User Acceptance Testing, and Regression Testing. • Led defect triage meetings with 4 offshore and 3 onshore resources, and managed test scripts and test suites using HP Quality Center for test repository, bug tracking, and reporting. • Attended Daily Scrum Meetings and worked on 2-week Sprints, collaborating closely with the Project Manager in the interviewing and hiring process. • Conducted data validation testing using SQL queries and participated in IVR Testing to ensure proper handling of DOL Fall Fund names as per the latest changes

Involved in Business Analysis and requirements gathering. • Performing Back End Testing by writing and executing SQL Queries and documented the issues with migration from development to testing. • Performing Data Analysis, Data Verification & Validation, Data Cleansing. • Transformation and Load (ETL) of data from Legacy systems using Data Stage. Creating SQL Queries using Oracle Databases and SQL Server for testing back end, Performed end-to-end testing. • Worked on HIPAA Rules and 21 CFR 11 in validating the patient’s data. • Worked on issues with migration from development to testing.