PROFESSIONAL SUMMARY:

• Over 18 years Software Test development, test execution, and analysis experience in Computer Systems Validation adhering to FDA and ISO guidelines. Strong working knowledge of CFR 21 Part 820.30 Design Controls of the Quality System Regulations, ISO 14971, and Software/Software Development Life Cycle Processes.
• Extensive experience in software testing, including test tool evaluation and validation. Wrote and executed test protocols for proprietary and off the shelf software. Developed, provided, and trained software development and software test team members at medical device companies on 510K / Submission approval, Software Hazard Analysis, and Risk Assessment and Risk Management. Utilized Agile, Waterfall and V - Model methodologies.
• Extensive experience working in GXP (GLP, GMP, GCP, and GDP) and GAMP regulated projects. Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification)
• Implemented formal testing methodologies utilizing manual and automated software procedures for GUIs and managing client/server application solution development.
• Extensive experience with CFR 21 Part 820; 21 CFR Part 11; ISO-13485 and ISO-14971:2007 for application of thorough Risk Management/Risk Assessment.
• Energetic and dependable contributor of effective technical solutions. Effective communications skills.

TECHNICAL SKILLS:

Hardware: HP 9000 series; Macintosh Power PC, SUN 4/300; IBM Risc, Wintel -Intel x86

Languages: Java2, Java Script, Ansi C, C++, PERL, HTML, CGI script (PERL; C), VB6, C++, and C#/Visual Studio 2010, Visual Basic, testing Python code.

Database: Oracle 9i, 10g (SQL), MS Access, MS SQL Server, PhpAdmin, Toad

Operating Systems: Windows XP, 7; UNIX, LINUX, AIX, HP-UX-11;VMS, DOS.

Test Tools: HP Quality Center, QC Functional Test, LoadRunner, QTP, TestDirector 7.0i, SQA Suite Team Test and Robot; Borland Silktest, Nohau 8051 emulator, LabView, Test Complete, Norton Ghost, Viewcomm, code debuggers, Serial Monitor, Minitab, Navision (ERP).

Software Development Support Software: Eclipse, Agitar, J-unit, FoxPro, DOORS 8.1 and 9.2, Visual Intercept, PVCS, PVCS Tracker, Mantis, SCCS, RCS, Framemaker, Interleaf, all MS Office tools, Requisite Pro. DICOM, Bugzilla, Perforce, Visual Studio 2010.

Software Development Lifecycle Methodologies: V-model, Waterfall, and Agile.

PROFESSIONAL EXPERIENCE:

Confidential, El Dorado Hills, CA

Quality Validation Engineer

Responsibilities:

• Developed and executed Installation Qualifications, Operational Qualifications, and Performance Qualifications for tools and fixturings for their surgical sawblade manufactured products, and developed Test Method Validations in accordance with FDA regulations 21 CFR part 820, ISO-14971:2007, GDP, and GMP. Utilized Minitab data analysis tool and provided software validation of Navision, an Enterprise Resource Planning (ERP) tool.

Confidential, Menlo Park, CA

Validation Engineer IV

• Evaluate software lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements, and 21 CFR Part 11 requirements. Lead and participate in reviews, risk analyses and other software quality assurance activities. Requirements gathering, test validation process analysis, software verification/validation. Updating the Menlo Park site's software validation process and identifying gaps in the procedures and current validation processes and mitigate the gaps to support the new software tool validation process.

Confidential, Ann Arbor, MI

Senior System Test Engineer/Lead

Responsibilities:

• Assisted in remediating FDA Consent Decree to support the QSIP (Quality System Improvement Program) concentrating on reworking existing test cases and developing new protocols, procedures, and traceability documents in an FDA regulated environment in accordance with 21 CFR part 820, ISO-14971:2007, GDP, GMP, for application of Risk Management for their CDI 1000 and CDI 500 operating room perfusion systems which manages blood gases and monitors flow rate of perfused blood. Analyzing existing code to identify issues that caused source of problems in the operating room blood gas analysis.
• Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification). Highly specialized effort based on previous experience with medical devices and FDA audits. Validated and implemented the HHD Serial Monitor Device Monitoring Studio software. Serial Monitor will intercept, display and analyze all data exchanged between the Windows application and the serial device and Terumo’s medical device, CDI 500 and CDI 1000 Monitors. It is successfully used in application development, device driver or serial hardware development and offers a platform for effective coding, testing and optimization for RS-232 and RS-485 protocols. Designed, developed, executed, and completed validation process for test protocol for the Blood Parameter Module Excel spreadsheet that executes calculations for blood gases.

Confidential, Plano, TX

Senior System Test Engineer/Lead to support

Responsibilities:

• Participation in cross functional teams focused on Quality Planning, Design review, design verification, process, Product/process verifications and validations.
• Review design input specifications based on customer requirements, review design output specifications based on product requirements.
• Develop test plans for development groups. Review requirements, specifications, schematics and flow charts, and recommend improvements. Review corrections to product issues in the defect management system.

Confidential, Rancho Cordova, CA

Senior System Test Engineer/Lead

Responsibilities:

• Researching and refining functional system requirements and system design specifications in accordance with company SOPs and FDA regulations and assist project manager in development of software requirements and Software Requirements Specification document.
• Assist software engineers in development of use cases, using Enterprise Architect, for rapid prototypes to elaborate functional requirement.
• Set up and maintain automation regression testing for projects using TestComplete and using Visual Studio on test machine and verify tests passed in the automated test suite. Testing DICOM communications protocol and data.
• Develop module and system tests and related verification and validation test plans for projects.
• Supervise, coordinate, and participate in verification and validation testing protocols.
• Troubleshooting and debugging of new electronic hardware/software systems.
• Responsible for hardware interfaces and low level aspects of embedded software products to support functional testing.
• Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification).

Confidential, Menlo Park, CA

Senior Verification Engineer/Lead

Responsibilities:

• Design and execute test cases for verification of software requirements, within an FDA regulated environment. Prepare and review test plans, protocols, and reports.
• Design and develop software test tools and utilities. Design and execute test cases for validation of software tools. Unit testing in Visual Studio 2008.
• Manage traceability between the software tests and the requirements/design/risk mitigation. Review software requirements, design, and code.
• Identify, debug, and document software implementation defects. Track and verify proper resolution of software defects.
• Extensive use and evaluation of TestComplete test tool for PDA.
• Participate in failure mode, hazards and risk mitigation analyses.
• Support regulatory submissions, and maintain GMP systems, including design controls, document and data controls.
• Test hardware assemblies and systems per automated protocols in LabView Modulation Tool Kit 4.2.1. Testing DICOM communications protocol and data.
• Responsible for following SOP, GMP, GAMP, GDP 21 CFR Part 11, and ISO requirements.
• Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification)

Confidential, Mountain View, CA

Quality Assurance Manager

Responsibilities:

• Manage Quality Assurance processes on FDA regulated project for medical device and related software. Develop test plans, procedures, and protocols. Execute and report results. Participate in Product Complaint management. Work closely with software development, regulatory, manufacturing, and sales team to assure product is developed with the highest quality adhering to all regulatory standards (21 CFR Part 820, ISO 13485), GDP, GLP, GCP and deployed product meeting project timelines. Agile methodology.

Confidential, South San Francisco, CA

Sr. QA Test Engineer/Lead

Responsibilities:

• Lead Software Test Engineer in the Commercial Information Technology (CIT) department on Managed Care (MC) Contracts and SFA Brands Maintenance and Enhancements projects. Lead software test responsibilities involved developing and maintaining test plans and test cases according to GDP requirements and managing test efforts of test team.
• Supported Saleforce.com (SFDC) projects. Utilized I-Many Master Data Management software which involved CARS testing. Used HP Mercury Quality Center software test support tool to develop, execute, and report on test execution results. Received for implementing and delivering projects on time and with successful deployment into production environment. Testing was performed on PC and Mac hardware supporting IE, FireFox, and Safari browsers. Assisted in User Acceptance Test teams for software releases. Agile methodology.

Confidential, Hercules, CA

QA Test Engineer/Lead

Responsibilities:

• Upgraded and maintained Borland Silktest project that provides automated testing for new version of a Java Swing application that drives a medical device which analyzes protein (proteomics) immunoassay analysis. Updated relevant test plans. Agile methodology.

Confidential, Foster City, CA

QA Test Engineer

Responsibilities:

• Designed, executed and managed manual and automated tests for Win XP/Vista and Linux based instrument software products to support a DNA sequencing and immunoassay analysis medical device. Utilized Borland Silktest automated test tool, T-Plan, XPlanner, DOORS 8.1, and the defect management tool TeamTest. Agile methodology.

Confidential, Menlo Park, CA

System Test Engineer/Lead

Responsibilities:

• Designed, executed and managed manual and automated tests on the Ambulatory Bioinformatics and Communication System (ABCS) within a regulated environment according to GLP, GCP, and GDP. ABCS is a web server application designed for the collection of biochemical assay information from Confidential t and consumer remote reader devices producing statistical data serving wide array of medical industry practitioners, pharmaceutical companies, researchers, and analysts. ABCS is a therapeutic monitoring system allowing pharmaceutical companies and healthcare professionals the ability to continuously gather and analyze biochemical data while a Confidential t is taking a drug either in clinical trial scenario, or post-market approval period. ABCS can also allow Confidential ts, caregivers, and users snapshot of their results while providing detailed and extensive information for technically trained professionals. Testing Python code.
• Develop detailed test plans from software requirements and technical design specifications. Testing ABCS web application using manual and automated test methodology using the Borland Silktest automated capture and replay test tool. Reported anomalies in Mantis bug tracking tool. Testing DICOM communications protocol and data. Data integrity was validated from the front end to the back end of the application with PhpAdmin database. Set up virtual machines for testing with VMWare. Produced the project development and test documentation to assure compliance with FDA regulations. V-Model, Waterfall methodologies. Provided programs for 510K submission, Risk Management and Software Hazards Analysis/FMEA. Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification).

Confidential, Folsom, CA

Senior Software Test Engineer/Lead

Responsibilities:

• Responsible for developing system/integration test plans, developing and executing manual and automated tests, writing test reports and tracking bugs. Utilized HP Quality Center automated test tool providing traceability between software requirements, test scenarios, test cases, variances, and enhancements of J2EE Enterprise Application deployed in a JBoss App Server. Develop detailed test plans based on software requirements and technical design specifications. While also being the HP Quality Center Administrator, duties included the design, development and executing test scripts with Quick Test Pro, Load
• Runner, and WinRunner automated test tools, and UNIX shell scripts to support data verification and validation. Define, track, report quality assurance metrics such as defect densities, find/fix ratios. Develop final test report for each product to document the quality issues found during the testing process so that fixes can be tracked. Perform analysis of J2EE based Applications in a JBoss Application Server. Development of requirements traceability matrix. SQL Query using the TOAD database tool. SDLC methodology.

Confidential, Pleasanton, CA

Senior System Quality Assurance Engineer/Lead

Responsibilities:

• Developed automated test environment for oximetry based software. Utilized the TestQuest automated test platform to develop software system and formal tests and procedures in accordance with FDA regulations. Software Test Team Lead for Oximetry software based medical devices, spirometers, and ventilators within GDP, GMP regulations.
• Provided SQA and V&V support concurrently for multiple FDA regulated projects. Utilized the automated test tools TestQuest, a C-based test language, and for LabView automated test software that uses a graphical programming language. Developed SQA Plans, Software Validation Test Plans, manual test procedures, automated test scripts
• Validation Test Summary Reports. Utilized the PVCS problem tracking tool and Requisite Pro requirements traceability and requirements management tool. Performed IQ, OQ, and PQ testing (Installation Qualification, Operational Qualification, and Performance Qualification).