Quality Assurance Engineer

Ruth L. Darby

***** ******** ***** 951-***-**** Celll

Temecula, CA 92591 ***********@*****.*** 951-***-**** Home

Self motivated, Work in a collaborative environment, Exercise SDLC,

Understand SW development processes, 11+ years experience as a quality

assurance engineer/analyst, 5+ years experience in the Healthcare Industry,

Methodical, Highly organized, Very detail oriented, Excellent Written and

Communication skills, High degree of intellectual curiosity.

Quality Assurance Engineer / Analyst

Lead and coordinate activities ensuring processes and products meet FDA

Regulatory Standards, Determine testing requirements and work estimates for

activities requiring validation including projects and change requests,

Quality Control, Quality Assurance Strategies, Software Testing, Hardware

Testing, Web Testing, Test Plan Standards, Test Cases, Test Scripts,

Functionality Testing, Data Warehouse Testing, Black Box Testing,

Regression Testing, Formal/Informal Testing, Users Acceptance Testing,

Ghost imaging experience, On Site Support, Strong problem-solving skills,

Perform hardware and software integration testing, Communicate and

Coordinate with project management and development team to plan releases

and release schedule.

Business Analyst

Requirements gathering, Document large scale IT applications including use

case development and user acceptance guidelines, Hazard Risk Analysis,

Project Schedule, Conduct User Acceptance Testing, Verify source documents

that information entered into the system is accurate and complete for

customer use, Use Patient health information (PHI) in accordance with

Health Insurance Portability and Accountability Act (HIPAA) standards,

Strong writing skills, Strong communication skills, Excellent

organizational and documentation ability to create and maintain detailed

documentation and procedures, Strong problem-solving skills, Deliver

successful validation projects on time and within cost targets, Support in

the development, review, and execution of computer system qualification

protocols IQ/OQ/PQ, Strong time management skills and prioritization

abilities, Organized and disseminate information efficiently.l

SOFTWARE: Silk Test Manager, Fogbugz, CaliberRM, Perforce, Citrix,

Perforce,Cognos, Infinity QS, Silk Manager,Wiki, Citrix, Visio, Visual

Source Safe, Documentum 6.5, Toad, Quick Test Pro, SharePoint, Crystal

Report, Remedy, VPN, FTP, Microsoft Office Suite products, Bugzilla, PVCS

Tracker, Doors, Domino, Ghost, Rational Suite.

PLATFORM: Windows 7, Vista, Windows 2000, XP Pro, XP Home,

UNIX, Oracle, Sybase, Windows95, Windows 98, Windows 98SE, ME.

ACCOMPLISHMENTS:

Information Technology PACE Award. 2009

Construx Web User Interface Certificate, 2008

InfinityQS User Interface Certificate, 2008

Construx Software Best Practices Certificate, 2007

PROFESSIONAL EXPERIENCE

Abbott Vascular contract with Select Source Nov. 2006 to Current

Temecula, California

Sr Quality Assurance Analyst

. Use Software Development Life Cycle Methodologies.

. Lead Quality Assurance teams.

. Use work streams (technology, user interface, and strategy).

. Design and implement new methods, procedures, and systems to improve

the processing and flow of information.

. Develop schedules and timetables to ensure the teams are meeting

project milestones and overall project goals.

. Write Test Plan, Test Specifications, Test Summary Reports, Test

Scripts/Cases, Release Validation Reports.

. Approve Installation Qualification Plan, Operational Qualification

Test Plan.

. Execute System Test, Regression Testing, Adhoc Testing, Negative

Testing, Functional Testing, User Acceptance Testing, Release

Validation Testing, Exploratory Testing.

. Deploy application code releases between Validation and Production

environments, Configure; install PC, Assign Scanner Business Users.

. Conduct interviews for Development and QA team candidates.

. Provide 2nd level support for hosted customers.

. Maintain staged copies of customer environments and reproduce customer

problems.

. Act as a customer advocate within business users to coordinate

business users meetings or conference calls.

Abbott Vascular contract with Select Source Nov. 2006 to Current

Temecula, California

Jr Business Analyst

. Develop Project Assessment, Project Schedule.

. Write Customer Off The Shelf Validation Specification.

. Write Software Validation Report.

. Analyze and develop product requirements.

. Document requirements via the approved process and templates.

. Write IQ/OQ Test Plans.

. Develop Design Specification, Hazard Risk Analysis, and Requirements

Traceability Matrix.

. Daily Software Business Users Support and meetings.

. Address software defects in team meetings, Attend Phase End project

reviews.

. Coordinate cross-functional task forces to identify and document

functional requirements, work flow, information sources distribution

paths, and system specifications.

. Perform knowledge transfer to other staff and review their work.

. Lead and influence others to implement change.

Abbott Vascular Contract with Select Source Nov. 2006 to Current

Temecula, California

Procedural Compliance Analyst

. Review compliance with company policies and procedures (e.g.

compliance with FDA, BSI, EEO, ISO regulations etc).

. Provide technical and business knowledge in the analysis of client

requirements in project areas such as: testing and product acceptance,

new business operating models with innovative approaches to IT

solutions.

. Communicate technical information to a non-technical audience.

. Develop the analysis and definition of efficient, cost effective

solutions which support client business processes and functional

requirements.

. Conduct analysis of client business processes and functional

requirements and prepare appropriate documentation to communicate and

validate the information.

. Maintain, develop and conduct SOP and GMP instructional classes for

personnel.

. Perform other duties as required.

Biosite Inc. Contract with On Call Technical June 2006 to Nov 2006

San Diego, CA

Project Lead / Software Quality Validation Engineer

. Complete Software Validation tasks assigned by the software validation

manager.

. Complete validation documentation and deliverables required to meet

company quality standards and regulatory compliance.

. Develop test protocols, test plans, test cases, test summary report,

release validation report.

. Execute System test, Regression test, Formal/Informal test, User

Acceptance Test.

. Follow established policies, processes and SOP's to support software

validation.

. Manual testing on Diagnostic Medical Devices.

Hospira Inc. (formerly Abbott Labs) August 2004 -June 02, 2006

San Diego, CA

Validation/Verification Test Engineer/Technical Writer (Contract Eastridge

Technical)

. Develop, Verify and Validate test requirements, test procedures, test

cases, test specification,

. Perform Regression Testing, Unit Testing, Formal Testing, Informal

Testing, System Test.

. Write requirements.

. Software and Hardware Manual Testing.

. Testing Plum A+ IV Monitor Medical Device.

. Attend requirement meetings and test procedure redlines meetings.

. Present ideas that will improve processes.

. Document/Report Defects using PVCS Tracker and Bugzilla.

. Communicate test results, analysis, and unresolved issues to upper

management.

. Coordinate departmental and cross-functional teams, focusing on the

delivery of existing products.

. Localization Testing (Greek, French, Spanish, Chinese, Japanese etc.).

. Work on different projects as needed.

. Follow FDA Rules and Regulations.

Hewlett Packard March 2003 - August 2004

San Diego, CA

Applications and Web Quality Assurance Engineer (Contract Volt Technical)

. Setup testing environments using Ghost.

. Software, Hardware, Internet, and Firmware testing.

. Localization Testing (Greek, French, Spanish, Chinese, Japanese etc.).

. Smoke Test software to verify that programs function according to

specifications and standards.

. Identify, analyze, document defects, questionable functions, errors,

and inconsistencies in software program functions, outputs, online

screens, and content.

. Establish benchmarks for program efficiency in operating and response

times.

. Create test cases and test data.

. Create and execute automated test scripts using testing software

programs (Rational).

. Install, maintain, and use build and testing software scripts and

programs.

. Respond to inquiries from users and tech support regarding functions

and operations of software programs.

. Contribute to establishment of standards and procedures for program

design and testing.

. Recommend program improvements or revisions to programmers and system

analysts.

. Review computer logs and reports to identify program processing errors

and possible improvements.

. Coordinate testing by users and third parties,

. Identify program variances from standards and suggest modifications to

conform.

. Assist users to isolate possible problems in software after

implementation.

. Conduct compatibility tests with other software programs, hardware,

multiple operating systems, and network environments.

. Monitor program performance after implementation to prevent recurrence

of program operating problems and ensure efficiency of operation.

. Document, track, and communicate test plans, test results, analysis,

and unresolved issues.

Anacomp Inc. January 1999 - March 2003

San Diego, CA

Applications and Web Quality Assurance Engineer (Full Time Permanent

Employee)

. Lead the day-to-day Web Presentment Quality Assurance activities.

. Develop test plans, test procedures, test cases.

. Data Warehousing testing, Test 3 Tiers, 2 Tiers.

. Perform Database Configuration (Oracle, Sybase, Iplanet).

. Execute unit test, beta test, regression test and acceptance testing

on software and websites.

. Conduct SQL queries to validate test data.

. Document and Report Defects.

. Provide high quality analysis of website defect and software defects,

. Exploratory and Ad hoc testing.

. Conduct performance and load testing of internet server application.

. Work as a part of the development team in evaluating options and

analyzing website and software defects.

. Review and evaluate product design.

. Planned and performed activities to support all QA requirements.

. Quality system ISO 9001.

. Managed Operations and Production day to day website(s) services for

pdfCD and Computer Output for Internet department.

EDUCATION

University of Phoenix, Phoenix, AZ 2010

Palomar College, San Marcos, CA 2008

Skill Path Leadership and Management Certificate 2000

San Diego City College San Diego, CA 1986

Southwestern College Chula Vista, CA 1985

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