SUMMARY:

• 6 years of strong experience as a Quality Engineer specialized in Medical Devices and Pharmaceutical industry.
• Experience with Medical Device/Desktop Applications, Web - based Applications, Embedded Software, and Standalone Applications.
• Well conversant with software testing methodologies including developing Test plans, Test scenarios, Test cases, Test procedures, Test reports and documenting manual and automation tests.
• Experienced in Agile Scrum model, involving in daily road maps and sprint meetings .
• Extensive experience in Manual Testing, Black Box, Functional, Regression, System Integration, End 2 End, Ad-hoc, Cross Browser, Compatibility and Regression testing .
• Expertise in designing/developing test frameworks using automation tools likes QTP (Quick Test Pro), and Selenium in automating functional, regression & UI test suits.
• Experience with GAP Analysis to check the compatibility of existing systems with new business requirements.
• Proficient in back-end testing using SQL commands on MySQL and SQL server databases in order to validate and view successful transaction of data.
• Experience on CLAIMS and HIPPA standard testing .
• Experience with software technologies MSSQL, Java Script, .Net, XML, and HTML.
• Experienced working with workstation applications, embedded devices, wireless medical devices, web applications, automated manufacturing equipment.
• Experienced in GUI, Load, Stress, Performance, Regression, Smoke and System to end testing.
• Developed and maintained Requirement Traceability Matrix (RTM) to cross-reference the functionality to the required protocols scripts.
• Excellent problem solving abilities, good analytical skills, verbal/written communication and good interpersonal skills with the ability to work as a committed individual and a motivated team player.

PROFESSIONAL EXPERIENCE:

Confidential, Indianapolis- IN

Senior QA Analyst

• Worked as a Quality Analyst for Medical software such as Quidel (Web-based application), GenePOC, and NeuModx (Desktop/Kiosk applications).
• Verification of various integrating modules that includes testing of developing functional software, embedded software, gap coverage, and instrument in the lab.
• Involved in testing Class II and Class III medical devices for compliance handling and worked with Quality System Regulations & Design Control requirements for FDA.
• Experience as a Functional Manual/Automation tester for Web & Client-Server Applications.
• Responsible for developing system test plans, ensures that software quality assurance ( SQA ) standards are met and validates business goals are accomplished.
• Used Quality Center to create to create Test Plan, Test cases and test scripts as well as steps for manual and automated implementation of test cases in Quality Center.
• Interactions with business analysts, developers, product owners & SME's in requirements analysis, review design documents, various documents related to testing in Agile, Scrum Sprint Environment.
• Excellent understanding of (SDLC) Software Development lifecycle. Experienced in Manual/Automatic testing and scripting as needed.
• Experienced using automation tools such as HP Quality, Selenium, Test Track Tool for scripting, executing, and defect tracking. Documentum, and Surround SCM for quality document maintenance/practice.
• Used SOAP UI tool to send request and verify the response back from services.
• Performed Database testing by creating and executing MSSQL queries to fetch the correct test results from the database.
• Handle the task of guiding quality assurance engineers in IQ/OQ/PQ activities and validation process.
• Used HP Quality Center for bug tracking and reporting, also followed up with development team to verify bug fixes, and update bug status.
• Perform responsibilities of developing testing methods, writing quality testing procedures, and checking quality to ensure compliance.
• Wrote SQL queries to perform database testing and to verify data integrity.
• Designed and developed various Ad hoc, Daily, Weekly, Monthly and year-end reports for the Business Analyst using SQL, Ms Excel, Ms Access and Teradata
• Created test scenarios, create test sets, write test cases and execute test cases. Execution of regression test sets. Also, did Performance testing, usability, User Acceptance testing (UAT), User Interface testing (UI) throughout the testing life cycle of the application.
• Responsible for planning and implementing quality testing procedures, scheduling project plans, and preparing documents.

Confidential, Highland Heights, OH

Quality Assurance Engineer

• Worked as a QA Analyst for the testing of R&D investment projects to improve software image quality and regulatory standards amongst the top global maker of medical imaging equipment, including X-ray, ultrasound, MRI, and CT scanners.
• Involved in testing Class II and Class III medical devices for compliance handling and worked with Quality System Regulations & Design Control requirements for FDA QSR, and ISO13485 for testing medical equipment .
• Supported the requirements analysis and testing activities done by the team of software engineers.
• Tested web services by generating XML SOAP requests and validated the corresponding XML SOAP responses
• Defined the detailed test design and code the test software and maintain software, design, and requirements by solving and testing defects.
• Involved in execution of Performance tests to achieve the 510 K deliverable.
• Participated in Corrective and Preventive Actions as appropriate with a proper deadline.
• Performed 510K testing and verification testing of QLab.
• Provide adequate documentation around V&V compliance for the regulatory requirements for computerized systems (21 CFR Parts 11, 210 & 820).
• Performed Risk Analysis on electrical and mechanical systems.
• Performed Root Cause Analysis on CT product failures and performed Validation & Verification for CT.
• Tested and validated CT operating software.
• Responsible for developing system test plans, ensures that software quality assurance ( SQA ) standards are met and validates business goals are accomplished.
• Responsible for writing the Test Cases and Test Scenarios based on the Functional Specification and technical Specification and documented in Quality Center.
• Created and maintained SQL Queries for back-end testing.
• Performed User Accepted Testing (UAT) and Production client support.
• Logged the errors, reported defects, determined repair priorities and tracked the defects until resolution using Quality Center/ALM.
• Extensively used SQL queries and procedures for data validation in both source system and target system.

Confidential, Parsippany, NJ

Quality Assurance Analyst

• Provided testing support for the design verification and validation of orthopedic devices with respect to patient safety and efficacy based on FDA guidance and industry standards.
• Used Quality Center to store all testing results, metrics, implemented Test plan, created Test Cases, Defect Tracking & Reporting.
• Performed SOA / Web Service testing using Soap UI.
• Generating draft SOPs, Work Instructions (WI) for Surgical Robotic Solution based on ISO 13485, ISO 14971 and IEC 62304 within 4 months focusing on Software V&V
• Prepared Test strategies, Test plans and Verification & Validation (V & V) Process Flow chart for PC DMIS 2014 Software and Windows 7 Implementation
• Review, modify and develop Test Plan. Review, Modify, and Develop Test Protocols, and Test Reports for Medical Devices
• Develop the proper documentations needed to show compliance with the Medical Device Standards.
• Developed verification and validation plans, developed and executed verification and validation protocols for Medical Devices.
• Used Quality Center to record documenting information useful in debugging process, evaluating test data.
• Actively involved with designing and developing test solutions for new and existing automated test systems and assisting team members with development and debugging efforts.
• Test and execute software validation tests for Digital Medical Imaging and other Medical imaging applications.
• Develop verification and validation plans/develop and executes verification and validation protocols for Medical Devices, Test report.
• Used Quality Center to analyze, track and report defects.
• Worked on uploading all Test cases to Quality Center for the current and prior releases.
• Performed extensive backend testing by writing SQL queries and excuting them into the database to verify the data integrity.
• Developed tables, Views, Stored Procedures and Triggers using SQL Scripting.
• Validating the multi-tiered software using the Software Development Life Cycle by authoring, approving and executing the following deliverables: URS, FS, and Risk Assessment.

Confidential, Deerfield, IL

QA Engineer

• Developed test plan, test cases using requirements, use cases, wireframes and design documents.
• Used Quality Center for reporting and tracking bug and generating reports.
• Involved in test strategies design and formulated the Validation Master plan, having analyzed the business model and software requirements.
• Ensured that the whole process complies with the 21 CFR Part 11 standards.
• Documented accept of the Computer Systems Validation (CSV) lifecycle in accordance with the FDA regulations including: Validation Plan and Protocols, Installation Qualification (IQs), Operation Qualification (OQs), Performance Qualification (PQs) specifications.
• Conducted routine internal inspections of regulated system (GMP, GLP, and GCP) to ensure that validations procedures have been in compliance with the company, divisional and the departmental policies.
• Developed validation master plan and validated ERP and SAP systems.
• Performed various cleaning validation technologies including Clean in place (CIP), Clean out place (COP), Immersion cleaning and manual cleaning.
• Performed Gap Analyses benchmarking a solid dosage process train with relation to current industrial standards.
• Performed Web Services testing and Validated XML request/response data using SOAP UI.
• Implemented manual test cases for each sprint task and executed them using Soap UI.
• Reported bugs and tracked defects using Quality Center.
• Performed Data Driven testing using automated scripts to check the functionality of the application.
• Validated the system SQL commands for backend testing on the database.
• Involved in documentation as to how to maintain and run scripts for future enhancements.