US_East | Software Developer - Testing Tools\/Automation\/Performance _L2

R2D2 # 10781379, 10781380Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential Submit candidates under their legal name and use only Capgemini templateRole: V&V TesterWork Location: Marlborough, MARate: $60.00/hr AILegal name:Location (City and State):Relocate?Rate:Availability:Phone #:Mobile#:Email address:Visa type:Hiring Status:If the resource has a visa, what company owns it? Are you working directly with the contractor's visa holder?Job Description5 Years of experience in medical device product verification, regulatory compliance, risk management, and SW hazard analysis activities for Class I, II, and Class III medical devices against FDA QSR 820, ISO 13485, AAMI TIR 45, FDA Validation guidance and IEC 62304 and GAMP-5 Computer System Validation (CSV) Writing Test Plans, Test Scenarios, Test Data and Test Case review based on FR. Tracking and Reporting Defects/Issues. Coordinating with Development team on Defect Reviews and Bug Triage process, CR Review, Effort Estimation, Traceability Matrix. Areas of specialization in testing include System, Integration, Functional, End2End, UAT and Database Testing. Very Good Exposure to Health care domains. Effort Estimation, resource planning and working along with team to meet the expected deliverables. Good working knowledge in all the phases of project development life cycle of different methodology like waterfall, iterative and agile scrum methodology. Development of Test Plans, Requirement Traceability Matrix and Test Summary Reports. Analyzing test results, tracking issues/defects, bug reporting and resolving tickets to closure.