Engineer Quality Assurance

Munir Gandevia

** ****** ******, **********, ************* 01803 ● 978-***-**** ● *********@***.***

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.

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.

Solid ability to join forces with peers, clients and technical specialists to expedite and ensure project success.

Constantly focus on optimizing software performance, reliability, usability, security and compliance.

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.

10 years of experience as QA lead

Professional Experience

Rapid Micro Biosystems, Lowell, MA 01854, 2016 to Current.

SeniorSoftware Quality Engineer.

Develop and implement SQA plans for GD2 systems.

Manage Test/QA Instrument and resources.

Manage and develop test cases for new feature development.

Manage Engineering and User testing.

Validate and deploy the daily SW build system.

Assist with defect management systems.

Manage and track inputs to the planning process.

Generate and present project test reports.

Validate Custom report, Error reporting Tool and Remote Monitoring system

Participate with compliance requirements for quality audits.

Analyze, track, and report on software quality to identify and mitigate areas of risk

Work with mechanical engineers and lab personnel on system software/hardware integration and issues investigation

Interface directly with project management on testing strategy, schedules, resource requirements, and status.

Assist customer support personnel to identify, track, and resolve issues related to product quality defects.

Picis Clinical Solutions Inc. / Harris Computer Systems-Picis-Optum, Wakefield, MA, 2008 to 2016

SeniorSoftware Quality Assurance Engineer

Proficiently use Quality Center’s Test Lab, Test Plan, Requirement and Defect modules to prepare and execute test plan and test cases for hospitals.

Efficiently coordinate all software Verification and Validation (V&V) activities for multiple projects.

As a key member of Software Change Review Group, meet regularly to review proposed software changes, implementation schedule, V&V requirements and V&V results.

Participate in code reviews and code walkthroughs, and organize test activities among offshore team.

Implement Agile/Scrum development methodology and verify compliance with HIPAA and ARRA requirements.

Screened, Interviewed, hired and mentored team of 15 SQA engineers

Reported Test report and activities to Project Manager, Product Owners and Scrum Masers at SCRUM of SCRUM meetings.

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, and tested product in a client-server environment.

Applied dynamic leadership talents toward guiding team in validation projects across several functional groups.

Continued …

Professional Experience continued … Munir Gandevia – Page 2 of 2

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.

Bayer Diagnostics, Medfield, MA, 2002

Lead Software Quality Assurance Engineer (contract)

Tested Rapidpoint Coag analyzer and Rapidpoint 400 blood analysis system, as well as Rapidlink software on Windows NT and 2000 platforms.

Ucentric Inc. /Motorola, Maynard, MA, 2000 to 2001

Lead Software Quality Assurance Engineer

Championed comprehensive testing of firewalls, FTP, e-mail server, web servers, print servers, network configuration, traffic, and back-up systems to optimize performance and reliability.

Selected, trained and directed entire QA team to fulfill software project goals and expectations.

Prior Background:

Senior Software QA Engineer, Giganet Inc. (acquired By Emulex Inc.), 1999 to 2000

Software QA Engineer (contract), Compaq, Littleton, MA, 1998 to 1999

Network Admin / CADD Automation Engineer, Fay, Spofford and Thorndike Inc., Burlington, MA, 1992 to 1998

Education

Civil Engineering, graduated with first class distinction, Govt. Polytechnic College, Valsad, India

AutoCAD, Middlesex Community College, Bedford, MA

Surveying, UMASS Lowell, Lowell, MA

MCSE & MCP Certifications, Clark University, Cambridge, MA

Software Test Automation (WinRunner, LoadRunner), Indham Inc. Burlington, MA

Technical Expertise

Software & Tools: Telelogic DOORS, PVCS Version Control, Test Track Pro, Accurev, ALM, SQL Profiler, Rally, WebLogic, WebSphere

Database: Microsoft SQL 2012, IBM DB2, and Oracle

Operating Systems: MS Windows,710,,MS Advanced Server, Linux, MAC, Solaris, Windows Mobile, AS/400/iSeries,IOS.

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