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Senior Software Quality Assurance Engineer
Healthcare & Medical Devices ~ Finance ~ Computer Networking ~ Mobile Telecommunications
Profile
Offer 15+ years experience in testing software for a variety of industries, specializing in validating products to comply with strict regulatory (e.g. FDA) requirements. Possess 10 years of experience as QA Lead.
Advanced knowledge of software development life cycle (SDLC) including quality assurance life cycle (QALC), and SQA strategy. Extremely well-versed in Agile/Scrum methodology.
Skilled at analyzing, creating and implementing test plans, cases, scenarios, procedures and scripts.
Expert in functional, integration, regression, performance, stress, system, acceptance, and front-/back-end testing.
Adept at preparing validation plans, requirements traceability metrics (RTMs), and validation reports in accordance with design specifications and SOPs.
Professional Experience
Philips, Andover, MA, 2017 to Present
Software Quality Assurance Engineer Connected Care Solutions & Analytical Informatics
Formulate test plans for patient care & monitoring solutions to validate medical device product performance.
Write and execute detailed test cases for implementation and deployment process using MTM, and frequently interface with project managers regarding testing to ensure rigorous adherence to defined parameters.
Review and diligently validate test plan using QMS (Quality Management System) and actively participate in classification meeting as key SQA resource.
Systemically integrate test with medical devices to assess adherence to QA criteria.
Establish efficient program to facilitate smooth knowledge transfer to team members, and educate team in new testing tools and techniques to achieve or exceed QA goals.
Work closely with customer to troubleshoot issues, identify root cause, and implement rapid and effective fixes.
Spearhead automation efforts to streamline and validate installation, upgrade, and migration process.
Rapid Micro Biosystems, Lowell, MA, 2016 to 2017
Senior Software Quality Engineer
Created and implement SQA plans for GD2 systems and produced test cases for new feature development.
Validated and deployed daily SW build system according to defined needs, meticulously tracked planning process, and played an integral role in all facets of defect management.
Prepared and presented comprehensive project test reports to key stakeholders and project managers.
Reliably validated custom report, error reporting tool, and remote monitoring system to ensure precise alignment with quality rules and requirements.
Participated in determining and evaluating compliance requirements for quality audits.
Methodically analyzed, tracked, and reported on software quality to mitigate risk and joined forces with mechanical engineers and lab personnel to drive seamless system software/hardware integrations.
Partnered with project management on testing strategy, scheduling, resource requirements, and process tracking.
Assisted customer support staff to in swiftly resolving related to product quality defects.
Picis Clinical Solutions Inc. / Harris Computer Systems-Picis-Optum, Wakefield, MA, 2008 to 2016
Senior Software Quality Assurance Engineer
Prepared and executed test plan and test cases for hospitals.
Efficiently coordinated all software Verification and Validation (V&V) activities for multiple projects.
Participated in code reviews and code walkthroughs, and organized test activities among offshore team.
Implemented Agile/Scrum development methodology and verified compliance with HIPAA and ARRA requirements.
Screened, interviewed, hired, and mentored team of 15 SQA engineers.
Reported test results to Project Manager, Product Owners, and Scrum Masters.
Kronos Inc., Chelmsford, MA, 2008
Senior Software Quality Assurance Engineer
Formulated and implemented complete test strategy for DB2 migration project using Agile/Scrum process.
Instrumentation Laboratory, Lexington, MA, 2008
Senior Software Quality Assurance Engineer (contract)
Thoroughly tested GEM4000 whole blood analyzer and GEMweb Plus integrated information management system to ensure stringent adherence to FDA standards.
Collaboratively devised automation test strategy and test plan to optimize QA functions and activities.
REZ1 Inc., Newton, MA, 2007 to 2008
Senior Software Quality Assurance Engineer
Wrote and implemented detailed test plans, cases and scenarios according to project requirements, and used Agile/Scrum methodology to facilitate efficient and quality-focused software development.
Achieved QA goals via extensive back-end, functionality, integration, and system-level software testing.
Decision Biomarkers Inc., Waltham, MA, 2005 to 2007
Senior Software Quality Assurance Engineer
Authored test plans, scripts and reports for validation of multi-mark express instrument, tested product in a client-server environment, and led team in validation projects across several functional groups.
Polaroid Inc. / ZINC, Waltham, MA, 2004 to 2005
Senior Software Quality Assurance Engineer (contract)
Composed test documentation to validate inkless printer s user interface, driver, and PC applications for Polaroid, and directed testing effort by SQA team in India.
Tested PictBridge and DPOF images, and printer drivers for use on Linux and Windows O/S.
Contrived effective test strategy to successfully attain certification from Microsoft.
Orange Wireless (France Telecommunication) Cambridge, MA, 2004
Lead Software Quality Assurance Engineer (contract)
Assembled test plan and script for projects, and conducted functional, integration and regression testing,
Traveled to UK for acceptance, integration, validation and verification efforts on behalf of clients in India, UK, Israel and other parts of U.S.
Nova Biomedical, Waltham, MA, 2003
Lead Software Quality Assurance Engineer (contract)
Developed test plans, validation protocol, and RTMs for handheld Glucose-Hematocrit Meter System in precise alignment with FDA guidelines.
Ensured flawless data communication between meter, patient data management system, central workstation, laboratory information system and hospital information system.
Partnered with QA engineer, VP of R&D, and Software Manager to prepare documents for 510k submissions.
Lead Software Quality Assurance Engineer (contract), Bayer Diagnostics, Medfield, MA, 2002
Lead Software Quality Assurance Engineer, Ucentric Inc. /Motorola, Maynard, MA, 2000 to 2001
Education & Training
Civil Engineering, graduated with first class distinction, Govt. Polytechnic College, Valsad, India
AutoCAD, Middlesex Community College, Bedford, MA
MCSE & MCP Certifications, Clark University, Cambridge, MA
Software Test Automation (WinRunner, LoadRunner), Indham Inc. Burlington, MA
Technical Expertise
Telelogic DOORS, PVCS Version Control, Test Track Pro, Accurev, ALM, SQL Profiler, Rally, WebLogic, WebSphere, Microsoft SQL, IBM DB2, Oracle, Windows, Advanced Server, Linux, MAC, Solaris, Windows Mobile, AS/400/iSeries, IOS
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