SUMMARY

• Qualifications include 6+ years of Software Quality Assurance Testing
• 4+ years of Experience in Quality Assurance of Medical Device / Health Care
• 4+ years Quality Assurance experience in a GMP or FDA regulated industry.
• Experience working in financial domain / with Banking application
• Experience with DOORS (Dynamic Object Oriented Requirements System)
• Experience with VM (Virtual Machine), HP QC (Quality Center ) and Git/Bit Bucket
• Experience in Black Box testing, Unit Testing, functional Testing, regression testing, Integration Testing, system Testing, Web services, Soap/UI Testing and Database Testing
• Strong analytical and QA/ testing skills, capacity for work and diagnostic ability, gathering different kind of projects requirement.
• Software development lifecycle SDLC experience, including requirement gathering, designing, developing and implementing test plans, test cases, test scripts and test processes.
• Experience working with Agile (Scrum) methodology, Water Fall models. Knowledge of Business process testing framework BPT.
• Knowledge of TFS (Team Foundation Server)
• Proficient in designing, reviewing and documenting system test plans, defining test procedures and creating test cases on the basis of product release features, client’s requirements and related technical documents
• Strong discipline with Process Validations and IQ, PQ, OQ.
• Working experience in Software Testing Life Cycle STLC, Bug Life cycle and Defect Management.
• Proficient in Test Plan formulation, Test Case design, preparing test data and writing test protocols.
• Experienced in defect tracking & defect management from the discovery of defects, submitting the defects and tracking the status in various defect tracking tools like ALM/QC, JIRA and BugZilla.
• Excellent written and verbal communication, interpersonal, intuitive and analytical skills proficient in data entry, Microsoft Outlook, Word, Excel and PowerPoint.
• Strong Critical thinking and Problem - solving skills
• Ability to understand applications from a technical as well as business perspective, diligent worker, self-starter, consistent performer
• Ensure that deliverables and deadlines are as per schedule.
• High proficiency in Scheduling, prioritizing and Managing resources and activities inQATeams

PROFESSIONAL EXPERIENCE

Verification and Validation Engineer/ QA Tester

Confidential, New Jersey

Responsibilities:

• Create and Analyze the business requirements documents.
• Write requirements and test plans.
• Create and execute detailed test cases/Test Protocols including prerequisites, detailed instructions and anticipated results.
• Perform testing includes functional testing, user acceptance testing, integration testing, regression testing, system testing, exception testing, compatibility testing of client/server and web.
• Participation in requirement review, test case review and defect triage meetings.
• Analysis and preparation of Regression testing Plan
• Logged and tracked defects using FogBugz, Project Management system.
• Ad-hoc testing of daily builds to comprehend readiness for formal verification.
• Experience in cross browser testing.
• Hardware and Software integration testing for medical device and application.
• Develop validation plan, Validation protocols, traceability matrices, test summaries, acceptance criteria and compile data and results into final validation summary report. Track deviations and change controls
• Dry ran existing Test Scripts. Prepare Validation Summary Report
• Create test methodology (test cases) to verify system functional requirements Provide effective support in all the stages of product development by applying quality engineering applications
• Verification and Validation of medical device software functionality and requirements
• Design, develop and execute functional test protocols
• Data Entry for test procedures.
• All procedures and documentation per federal Food and Drug Administration Quality System Regulation and company procedures
• Worked in laboratory environment using lab safety precaution.
• Generate techniques of quality-engineering to test medical devices
• Contribute to Medical Device Software life cycle process implementation per IEC 62304 standard
• Manage/qualify electronic laboratory test equipment perISO17025,ISO14971,& FDAQSR(21CFR:820)
• Apply standards for Software Quality methods, processes and procedures which meet internal and external regulatory requirements and implements against them

Quality Assurance Test Engineer

Confidential

Responsibilities:

• Analyzed Business Requirements documents and interacted with developer and business analyst.
• Design and Implement Test Strategy, Test Plan, and Test Cases.
• Involved in designing end to end test cases for web screen and console application
• Experience of Validation with accounting / banking application.
• Create Test Plans for Manual Testing, Functional testing, System Testing, Integration Testing, Performance Testing, Regression Testing & reviewed their consistency with the business requirements
• Working experience with HP Quality Center
• Working experience with SDLC
• Responsible to executing all test script while FUT and SIT cycle
• Responsible for documenting any bug or failure of test scripts
• Performed Load testing for Web forms and console/job applications.
• Checking SLA criteria and report failure where it doesn’t match expected SLA.
• Manually checking syndicated data in DRM (Oracle Data Relation Management Server)
• Responsible Helping business users for identifying bugs in Production by replicating scenario on lower environment
• Working experience with Bug Management tool JIRA

Quality Analyst / QA Tester

Confidential, New Jersey

Responsibilities:

• Involved in entering requirements, developing test plan tree, designing the test steps, writing test cases and executing test scripts using Test Management Tool Quality center.
• Created test cases, executed and recorded results of test cases usingQualityCenter
• Worked On Confidential project in all Phases of SDLC, Requirement, Analyze, Design, Testing, Maintenance
• Wrote Modification Request for bugs found during test execution.
• Used JIRA for defect tracking, issue tracking and Confidential Project Management
• Responsible for testing of both, The Admin Module & the End Users Module for Confidential .
• Developed and maintained the Traceability matrix between requirements and test cases.
• Involved in analysis and study of functional specifications for the enhancement of existing functionality.
• Performed browser compatibility testing using different browsers like IE, Fire Fox etc
• Wrote Test Plans, Test Cases transactions like sales, redemption, activate coupons and refunds.
• PerformedNegative testingto find how the functions and variables perform when they encounters invalid and unexpected values
• Involved in integration Testing, Functional Testing, Regression Testing, End to End Testing, User Acceptance testing.
• Regularly interacted with Developers to discuss various problems and issues & Follow up with defects.
• Worked closely with Business and UAT groups and provide support during UAT
• Responsible to present walk-through with clients as part ofUAT.

Quality Analyst / QA Tester

Confidential

Responsibilities:

• Experience with Connex Platform software
• Developed the test requirements, test plans and test cases as per the approved business requirements.
• Demonstrate working knowledge of current and applicable GMP regulations e.g.: ISO13485 / 21 CFR Part 820. working knowledge of electronic laboratory test equipment per ISO17025, ISO14971, & FDA QSR (21CFR:820)
• Verification and Validation of medical device software functionality and requirements
• Support equipment, process and computer system validation by participating in the development of studies and validation protocols to assess manufacturing capability/reliability.
• Involved in all stages ofSTLCstarted from requirements gathering to Analysis, Testing and Deployment of the entire project.
• Work with Developers to Gathered requirements by interacting with marketing team and preparedSoftware Requirements Specification (SRS)and other supporting documents.
• Test Connectivity of Medical devices to the server
• Test WCF Services
• Test Reports for data accuracy and format
• Involve in integration Testing, Functional Testing, Regression Testing, End to End Testing, User Acceptance testing.