SUMMARY:

Successful Quality Assurance Leader with ten years hands - on experience in quality project delivery specializing in Software Quality Assurance and FDA Validation Testing. Experience in contributing to both small and large companies managing in-house and outsourced teams.Experience managing end to end project processes, designing test strategies and collaborating with project teams. Efficient in motivating team members and delivering high-quality products to production on time.

PROFESSIONAL EXPERIENCE:

Confidential

Senior Software Quality Assurance Engineer

Responsibilities:

• Responsible for leading SQA efforts in multiple internal and customer facing applications from initial planning to go live in a GxP validation environment.
• Collaborated with Project Managers, Business Systems Analysts, and Developers to provide direction on quality governance for GPRS and PLATO drug applicant tracking systems. Both systems were windows applications running on a java/oracle backend.
• Responsible for all aspects of document creation and review of User Requirements, Functional Specifications, Test Plans and Validation Protocols according to System Development Life Cycle and Computer System Validation regulations.
• Lead the quality team through the development of SQA/Validation Test Plans, Test Procedures, SQA standards and tool requirements.
• Managed work of onsite and offshore SQA testers.
• Worked with Scum/Agile development using Jira.
• Mentored team members in testing processes and testing tools in order to execute Test Plans as required.
• Identified opportunities for process improvements that streamlined testing activities while minimizing risk. Implemented a defect management process using HP ALM.
• Reduced SQA documentation to maximize testing time and leveraged SQA scripts to reduce Validation efforts. Facilitated risk mitigation meetings and provided integrated solutions to determine impact of development activities. Prepared reports and status updates for business sponsors and upper level management on quality status and delivery dates for multiple projects.
• Analyzed business requirements, performed gap analysis, documented SQA process.
• Coordinated the testing of multiple OS/browser environments for JBoss upgrades and performed the interface integration testing to confirm applications remained in sync.
• Coordinated and performed testing of Data Migration projects from HP QC to HP ALM and also an MDMS Integration which involved field value transformation/population rule changes from one system to another.
• Planned and executed functional testing on applications and systems using manual and automation testing. Peformed data verification testing using SQL scripts.
• Tested web-based and database applications (Medidata Rave) designed for the management of clinical trials in client/server and web-enabled environments within the Informatics Clinical Data Management group to ensure that the EDC systems remained in a validated state.
• Wrote and executed SQL scripts to test and verify Clinical Data mappings and data extraction of cloud based clinical trials and patient drug safety information, across multiple JBoss servers.

Confidential

Software Quality Assurance Engineer

Responsibilities:

• Contributed to several time critical projects involving the successful repair and enhancement of system functionality to meet customer expectations.
• Created and maintained project SSRV spreadsheet to track project status through completion.
• Revised functional specifications with marketing and development teams prior to formal validation testing. Performed thorough validation of systems ensuring all documentation of requirements and specifications for testing tools, web-based server applications and embedded systems were clearly defined, traceable and free of ambiguity.
• Utilized HP Quality Center to develop test plans, test cases for black box, regression and performance testing and collect test evidence for FDA 510k approval.
• Performed N-tier client/server testing for real world test environments for hospital domains and system integration on all required operating systems and network configurations.
• Wrote SQL statements to test data flow and to perform data analysis to identify defects. Performed data verification testing to verify patient critical data was transferred correctly from drug infusion pumps to hospital domain networks.
• Verified Operational Qualifications (OQ) and Performance Qualifications (PQ).
• Utilized WCF and MSQM enterprise communication technologies, IIS, Active Directory and networking topology on Windows Server.
• Conducted load performance testing using Load Runner.

Confidential

Software Quality & Assurance Engineer

Responsibilities:

• Worked closely with a cross-functional team of senior management and marketing to define goals, deliverables, resource management and product specifications resulting in increased company profitability.
• Improved process management, cross-tier communication and organizational structure resulting in an increased efficiency and reduced redundancy.
• Trained and mentored all new/temporary employees, speeding up their integration time within the company.
• Wrote and maintained suite of test plans and test scripts and wrote proposals for future versions of the software.
• Tested Confidential ’s complete suite via Windows OS, Mac OS and web and mobile devices.
• Effectively documented software and hardware defects for integration into regression test case suite.
• Performed mobile-web testing, integration testing, system testing, black/white box testing, data portal testing (CHS call, feedback service and data tracking) and smoke testing of new builds.

Confidential

Software Test Engineer

Responsibilities:

• Performed Q&A Testing for ABL80 embedded medical devices for blood gas analysis, using FDA standardized test plans, test cases and protocols.
• Managed and maintained status of testing deliverables for weekly sprints in Version One: Agile Team.
• Participated in creation of department-wide test procedure standardization style guide.
• Validated ABL80 suite of analyzers ensuring all documentation of requirements and specifications for testing tools, web-based server applications and embedded systems were clearly defined, traceable and free of ambiguity.
• Setup, installed, and configured 3-tier radiance server for systems integration testing between ABL80 CO-OX, FLEX and BASIC platforms.
• Executed SQL queries for the verification that HL7 messages were properly stored in the SQL server database and converted into XML for patient admit discharge transfer (ADT).
• Utilized Alchemy CATALYST Lite to validate regional string translation in multinational localization testing.