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Verification And Validation Lead Resume

San Jose, CA

PROFESSIONAL SUMMARY:

  • Lead/Senior Engineer in Software Quality Assurance, Software Verification & Validation, Software and Instrument, UAT, CSV, Confidential QSR, ISO, GxP, MDD, GAMP5
  • Medical Devices, Pharmaceuticals, Biotechnology -
  • 15+years wide-ranging experience in Software Quality Assurance, Software Testing, Software Verification and Validation, Build, Release and Configuration management for Medical Devices, Pharmaceuticals and Biotechnology industries.
  • Extensive experience in Confidential regulated Medical Device, Biotechnology and Pharmaceutical industries. SQA team lead experience on large and complex projects, setting up SQA environment and infrastructure, defining quality strategy, directing SQA activities, leading and coaching junior SQA staff.
  • In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, MDD 93/42/EEC, SOX, CLIA, GAMP, GxP, SEI CMM, IEEE, IEC/EN/AAMI/and Confidential Quality Systems Regulations (21 CFR Part 820 and 21 CFR Part 11 to meet the regulatory compliance in developing and implementing test plans, test cases, test scenarios, test procedures, and running complete test cycles in Agile/Scrum environment.
  • Extensive hands-on experience in white, gray and black box testing of standalone, Client/ Server, and Web-based applications on all stages of Software Development Life Cycle. Working knowledge in establishing SQA automation objectives and strategies across multiple projects utilizing state of the art automation tools and technologies. Test automation development in C, Silk (4Test), Shell (sh, ksh, bash), and Perl scripting in Windows, UNIX, and Linux environments.
  • Familiar with MFC, Web 2.0, NET, COM, DOM, Active Directory, Source Code Control, SCM, DLL, Multithread Process, Internationalization (L18n), Localization (L10n), SaaS, LDAP, SAP, DICOM, HIPAA, Medical Devices, Clinical Trials, In Vitro Diagnostic (IVD) Devices, Medical Diagnostic Imaging, Control Systems, Robotics, Embedded, Software Calibration, LAN/WAN

TECHNICAL SKILLS:

Hardware: IBM & PC Compatible and Mac. Installed SCSI Cards, IDE, Hard DrivesNetwork Cards (Ethernet, Token Ring), CD ROMs, Modems, USB

Operating Systems: Windows /NT4/ME/XP/Vista/7/8/10/CE, Unix (Solaris, BSD), LinuxVxWorks

Test Tools: QA Partner 4.5, SilkTest 10, AstraLoadTest 3.5, MS Stress Tool 1.1 WinRunner, LoadRunner, TestComplete, Network Monitor, QA DBTester, QTP

Databases: Oracle 8, MS SQL Server 7, Verity Engine, File Maker Pro, Sybase

Applications: IIS, Web 2.0, WebLogic, Apache, MS Visual Studio, TFS, MTM, Silver Light, Share Point, Passolo, Agile PLC, Omnify, VMware, AutoCAD R14, SolidWorks, Pro/ Confidential, VisioInstallShield

ERP/CRM: SAP, Oracle EBS, Microsoft Dynamics, Salesforce, Siebel, Workday, NetSuite, Veeva

Communications Packages: CGI, Unix Internals, TCP/IP, DNS, WINS, HTTP, SOAP, DHCP, NDDS RTI

Languages: C, VBScript, HTML/XML, JavaScript, 4Test, TSL, Perl, 4NT batch, Fortran

Web Design: Allaire HomeSite 4.5, MS FrontPage, Claris Home Page, NetBeans, Filemaker

SCM Tools: Codesion, SVN, CVS, TFS, Perforce, ClearCase, Visual SourceSafe, Ant, MavenHudson

Bug Tracking: HP ALM, Test Director, Soffront Track, ClearQuest, MKS Track Integrity, JiraJama, Bugzilla, Remedy, TestTrack Pro, Elementool, Trac

Test Requirements- Case Management: DOORS, HP ALM, MKS Integrity, RequisitePro, TestTrack RM, CaliberClearQuest

PROFESSIONAL EXPERIENCE:

Confidential, San Jose, CA

Verification and Validation Lead

Responsibilities:

  • Leading verification and validation activities providing hands-on leadership across Confidential medical devices system development process for Chromatography and Mass Spectrometry Systems.
  • Defined and developed V&V strategy for integrated medical device systems with Electro-Mechanical, Fluidics, Optics, Electronics, Embedded Software and Disposables.
  • Performing as hands-on V&V Engineer authoring and executing SDLC deliverables such as URS, SRS, FRS, DDS, RTM, Unit, Integration, Commissioning Protocols, Manufacturing Equipment Qualification, UAT, Delta V, FAT, SAT, Validation Planning, IQ/OQ/PQ and Validation Summary Report.
  • Developing test approach, test design, test plan, test procedures, scripting, algorithm verification, FMEA review and risk management, executing testing with engineering traceability to ensure completeness, accuracy and testability of product requirements.
  • Creating SOPs for software processes, such as software verification and validation process, software change control process, software CAPA and FMEA according to company’s quality management system, Confidential regulations and international standards.
  • Performing verification test on embedded control system software (Windows Embedded CE 6.0, VxWorks 7) to integrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios.
  • Coordinating software verification and validation (Unit Testing, Code Walkthrough, Functional Black Box/White Box testing, Intended Use/System testing) to ensure that software is validated in accordance with established requirements and procedures.

Confidential, Foster City, CA

Lead SQA Engineer

Responsibilities:

  • Leading verification, validation and software testing for Oracle EBS DR (Disaster Recovery) annual test exercises for the enterprise integrated applications of Oracle Confidential -Business Suite.
  • Authoring Disaster Recovery SOPs and plans, managing IT Disaster Recovery Program partnering with the cross-functional Network/Security/Platform/Database/Application Production Support teams.
  • Guiding software validation team in creating quality documents adhering to GAMP5, Confidential 21 CFR Part 820, CFR Part 11, CFR Part 210, CFR Part 211 and EU Annex 11 requirements.
  • Using risk-based approach (ISO 14971 Risk Management and GAMP5) to determine the scope of validation for GxP compliant systems with appropriate justification of the testing approach.
  • Working on SQA test planning, test scoping, re-imaging, configuring installation, deployment, resource allocation, administering and troubleshooting software test environments.
  • Performing integration testing that covers business process transaction flow between Gilead Oracle EBS Ecosystem and its boundary applications.
  • Testing business processes covering Plan to Make (PTM), Procure to Pay (PTP), Order to Cash (OTC), Order to Report (OTR), Account to Close (ATC), Shipping Execution (WSH), Warehouse Management System (WMS).
  • Supporting and maintaining Quality Assurance programs, policies, procedures and controls ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements and guidelines.
  • Managing HP ALM (Application Lifecycle Management) 11.0 to manage requirements, test planning, test execution and traceability.
  • Participating in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes to ensure and document that GxP systems are maintained in the validated state in Production.

Confidential, Concord, CA

Lead Software QA Engineer

Responsibilities:

  • Leading Confidential software verification and validation activities as a part of the overall software development process for Liberty Automated Peritoneal Dialysis and Hemodialysis Delivery Systems.
  • Defining and developing V&V strategy for integrated medical device systems with Electro-Mechanical, Fluidics, Optics, Electronics, Embedded Software and Disposables.
  • Ensuring V&V documentation compliance with Confidential 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, IEC 62304
  • Developing test approach, test design, test plan, test procedures, scripting, algorithm verification, FMEA review and risk management, executing testing with engineering traceability to ensure completeness, accuracy and testability of product requirements.
  • Creating SOPs for software processes, such as software verification and validation process, software change control process, software CAPA and FMEA according to company’s quality management system, Confidential regulations and international standards.
  • Performing verification testing on embedded control system software (Windows Embedded CE 6.0, VxWorks 7) to integrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios.
  • Coordinating software verification and validation (Unit Testing, Code Walkthrough, Functional Black Box/White Box testing, Intended Use/System testing) to ensure that software is validated in accordance with established requirements and procedures.
  • Contributing to Confidential (Software Change Review Group) and Confidential (Software Planning Group) meetings to review defect fixes/proposed changes, implementation schedule, deliverables, V&V requirements; V&V results; and to recommend software release.
  • Providing Software Quality Assurance technical guidance/training and support to all departments that develop or use software to ensure product quality and safety and conformance to regulatory requirements.
  • Managing software release and implementation activities. This includes revision control, configuration management, and installation of approved software in Production Manufacturing areas.

Confidential, Foster City, CA

Lead Software Validation and Verification Engineer

Responsibilities:

  • Leading SQA, validation and verification of GxP computerized systems in compliance with 21 CFR Part 11, Eudralex Anex 11, GAMP 5, SOX, PIC/S, HIPAA, SOPs guidelines) performing testing of multiple applications/systems: TrackWise 8.4, Documentum D2, and LiveLink OpenText.
  • Analyzing the systems and the processes used in a GxP environment with business, quality, and technical individuals to ensure the compliance of the applications and the systems with Confidential, ISO and SOX regulations and standards.
  • Working on SQA test planning, test scoping, re-imaging, configuring installation, deployment, resource allocation, administering and troubleshooting software test environments.
  • Participating in requirements development, software design reviews, testing, configuration, go/no go decisions and reporting.
  • Using risk-based approach in compliance with EN/ISO 14971: 2012 Risk Management to determine the scope of V&V for GxP systems to develop documentation and verification activities with appropriate justification of the test strategy and approach.
  • Authoring and guiding the team in preparation of V&V package that includes URS, FRS, Design Specification, Test Plans, Risk Assessments, Risk Management Plan, Test Procedures, Test Traceability Matrix, and Test Summary Reports
  • Performing validation of data migration on Oracle 11.2.0.3 on Source DB, Target DB and Staging Area. Migration qualification includes set up, pre-migration activities, execution of migration code, collection of migration logs, direct data mapping, and verification of migrated case workflow.
  • Managed electronic routing of required documentation ensuring compliance to current procedure for Confidential -approval. Communicating status, solutions, concerns in a timely manner within the team to facilitate and address issues within the projects.
  • Participating in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes to ensure and document that GxP systems are maintained in the validated state in production.
  • Identifying and resolving quality/compliance issues in documentation resulting in reduction and closure of validation discrepancies.

Confidential, San Ramon CA

Software Test Lead

Responsibilities:

  • Led V&V of EMC Documentum D2, setting up enterprise standards for development and validation of Enterprise Level Documents and Content Management Solutions.
  • Analyzed system’s functional specifications, developing and implementing test plans, test cases, test scenarios, and test metrics. Run complete test cycles for each product revision.
  • Tested the migration of the legacy systems documents and metadata (FileNet, SharePoint, Protégé, DoCTR) to Documentum D2.
  • Tested integration of Documentum D2 to SAP Work Management (WM) module to manage document and data connectivity, and associated regulatory compliance processes within the context of SAP application objects.
  • Performed integration testing of Documentum D2 with Enterprise Integration (EI) web services built on SOA Architecture.
  • Used SoapUI 4.6.0 tool to validate web services that utilize the standards like XML, WSDL, SOAP and Java Message Service working on different servers (Oracle WebLogic, Apache Tomcat).
  • Validated the process of Lifecycle Management workflows for automatically promoting files in workflow tasks (Review/Approval, Version Management, and Change Control) to the next state in the lifecycle.
  • Led V&V activities for implementing Documentum software upgrades across multiple development, Test, QA and Production environments (Apache, Weblogic).

Confidential, Palo Alto, CA

Software Quality Lead

Responsibilities:

  • Led SQA team developing and maintaining software verification and validation of product, non-product and infrastructure projects under Confidential, ISO, cGMP and GAMP.
  • Authored V&V package (V&V Test Plan, Risk Management Plan, Test Cases, Compliance V&V Plan and Report, V&V Test Summary Report.
  • Participated in requirements development, software design reviews, testing, configuration, go/no go decisions and reporting.
  • Supported software team to establish software lifecycle processes and infrastructure for the processes.
  • Performed V&V of design controls to ensure the compliance with Confidential QSR, CLIA, ISO 13485, ISO 14971, IEC 62304 and MDD.
  • Conducted SDLC Agile model for software V&V of manufacturing environment, performing software validations on software for instrument controls, quality data tracking and system software.
  • Managed HP ALM (Application Lifecycle Management) 11.0 to manage requirements, test planning, test execution and traceability
  • Performed data integrity testing on Microsoft SQL Server 2008 to access and manage the Database Engine, Analysis Manager, and SQL Query Analyzer.
  • Conducted software testing on Saba LMS application hosted and delivered via Software-as-a-Service (SaaS) model with an impact on Performance, Network Security, System Backup, Disaster Recovery, Data Integrity and Record Retention.
  • Provided validation representation of Change Control Board to ensure and document that GxP systems are maintained in the validated state in production environment.

Confidential, Hayward, CA

Software Test Lead

Responsibilities:

  • Led software testing and V&V activities on OptiScanner, an automated, plasma-based bedside monitoring system intended to manage patients’ target glucose level.
  • Performed testing and V&V of design V&V, software, embedded control system (Windows CE, VxWorks), Electro-Mechanical, Fluidics, Optics, Electronics and Algorithm.
  • Responsible for overall testing strategy, test planning, test case development at all Testing Phases including Unit, System, Integration, Performance, Security and UAT.
  • Developed SOPs for 21 CFR Part 11 Electronic Records; Electronic Signatures and IEC 62304 Software Life Cycle Processes to ensure compliance with Confidential QSR.
  • Authored URS, SRS, Software Design Verification and Validation Protocols, Design Control Plans, Trace Matrices, Validation Summary Reports, Qualification Protocols.
  • Supported Bugzilla bug tracking system, working with the development team on reported issues. Chaired CCB to set priorities, resolve issues and escalate testing.
  • Performed installation, programming and testing of real-time embedded software on Instrument part of OptiScanner medical device.
  • Continually researched and recommended new tools, technologies, mechanisms and process improvements to accomplish more efficient and productive environment for achieving the highest quality products.

Confidential, Alameda, CA

Sr. Software QA Engineer

Responsibilities:

  • Participated in software V&V of Confidential Diabetes Care Orion project, the Therapy Management System software and medical device (Insulinx glucose meter).
  • Worked for the verification engineering team, developing and maintaining verification and validation of product, non-product and infrastructure projects,
  • Authored and maintained V&V documentation deliverables that comply with Confidential CFR Part 820, Confidential CFR Part 11, cGMPS, ISO 13458 and HIPAA guidelines.
  • Performed design verification and validation to ensure that design control process is in compliance with QSR, CLIA, ISO 13485, ISO 14971, IEC 62304 and MDD.
  • Utilized Rational DOORS requirement management system as a company tool to follow requirements traceability during design and development process.
  • Used DOORS as verified electronic signature system for protocol approving and execution with output to formal documentation (DHF, DHR, DMR) that is reviewed, approved and controlled in Agile product lifecycle management system.
  • Queried and verified Oracle database tables using EO Modeler and SQL Plus.
  • Executed SQL, Perl, and UNIX scripts to perform updates and queries in a real-time relational database engine.
  • Supported Support 510K submission, TUV testing, and Confidential approval process.

Confidential, Palo Alto, CA

Sr. Software Verification & Validation Engineer

Responsibilities:

  • Performed software verification and validation of Confidential medical devices for radiotherapy, radiosurgery, proton therapy, and brachytherapy treatments.
  • Defined test strategy, designed and developed V&V documents form software requirements, architecture designs, and code of complex embedded real-time systems.
  • Ensured the compliance with Confidential QSR design control requirements 21 CFR Part 820.30, 21 CFR Part 11, IEC
  • Led software verification and validation activities on Novalis Tx™ radiosurgery system with 4D imaging using PET/CT scanners, respiratory gating and IMRT (Intensity Modulated Radiation Therapy).
  • Developed and maintained V&V project schedules, CCB chairing in cross-functional team environment and providing engineering test support during all phases of SDLC.
  • Supported training of personnel in requirements of quality tools and techniques, QMS based on ISO 13485 and Confidential 21 CFR 820 regulations.
  • Verification testing on embedded control system software (VxWorks) to intergrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios.
  • Performed Varian’s products Internationalization (L18n) & Localization (L10n) testing using Trados and SDL Passolo software localization tool.
  • Performed Confidential character sets verification, text filters, hyphenation, spelling, and sorting rules.
  • Tested for language translation, data formats and setup options, culture-bound graphics and output, National Language Support (NLS), DBCS, Unicode normalization, locales and languages.

Confidential, Davis, CA

Software Quality Lead

Responsibilities:

  • Performed software quality assurance, testing, build, release management and deployment of software for Confidential products under Confidential, ISO and GxP standards and regulations.
  • Reviewed and analyzed software requirement, design and product specifications, developing and executing qualification test plans, test procedures, test scenarios and test cases.
  • Run complete test cycles for each product release monitoring and analyzing test results, collecting test metrics and conducting test reporting.
  • Performed verification, validation, simulation, end-to-end testing, debugging, defect isolation, and fixes of new software that provide control, communications, and power distribution for virtually any remotely operated system with multi-carrier real devices.
  • Maintained and administered the Build System that include Subversion, Visual SourceSafe, Visual Build Pro 6 and InstallShield that power a complete build process.
  • Prepared Confidential CFR Part 11 Gap assessments to develop CSV remediation plans to improve the business process and the efficiency of GxP computerized system.
  • Participated in Change Control Board (CCB) activities with the cross-functional group (R&D, Systems Engineering, Affairs, Marketing and Operations).
  • Led the activities for continuous development and improvement of all engineering team quality policies and processes in accordance with Confidential and international standards for medical devices.

Confidential, Clara, CA

Senior Software Verification & Validation Engineer

Responsibilities:

  • Performed V&V of medical devices, VISX WaveScan and Confidential Excimer Laser Systems software and firmware under Confidential, ISO and GxP standards and regulations.
  • Performed design verification and validation to ensure that design control process is in compliance with Confidential QSR, CLIA, ISO 13485, ISO 14971, IEC 62304 and MDD.
  • Analyzed system’s functional specifications, developing and implementing test plans, test cases, test scenarios, and test metrics. Run complete test cycles for each product revision.
  • Comprehensively performed unit and system level software testing/troubleshooting and documented software issue reports to be tracked and resolved.
  • Participated in Change Control Board (CCB) reviewing proposed change control, assisting in the validation impact assessment for GxP systems.
  • Developed and implemented a Web interfaced test case management database for test case creation, management and execution based on File Maker Pro 5.0 platform.
  • Worked in a fast paced team environment to interface regularly with electrical, back-end software, mechanical and system test engineers on system level design and test development.

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