Quality Assurance Engineer

David J. Ault

408-***-**** San Jose, CA ***** *********@*****.***

SUMMARY:

Many years of industry experience with Medical Devices and complex instrumentation qualifications. Performing Verification and Validation Testing of Instrumentation products supported by external workstations, networked, or embedded firmware in a Government regulated environment.Wrote, edited & maintained: Master Requirements documents, Test Plans, Test cases and Final Reports, Technical Manuals for Manufacturing Process Sop’s, Assembly, and Test & Troubleshooting Knowledge base in a DFM/JIT manufacturing environment. Working knowledge of Laboratory, Manufacturing, GMP\QSR, and ISO environments, standards ISO 13485, 21 CFR part 11 and 21 CFR 820, ClearQuest.Performed Software and Hardware quality and reliability tests, and issue status progress and escalation as appropriate throughout development life cycle.Two Patents applications pending in 2011: DNA minichip with accelerated hybridization and liquid array DNA micro array chiplet.

Professional Experience

Senior System Quality Assurance Engineer: Affymetrix Incorporated, Santa Clara, CA 2008-2011

Industry Leader in GeneChip Microarrays Technology

Documentation

Wrote detailed test instructions that adhered to hardware and software requirements. Produced standard operating procedures for the quality assurance of calibration, measurement, operation, installation, and the troubleshooting of hardware electromechanical systems and sub-systems to close tolerances. Documented and wrote test results reports, wrote system test plans, test cases, traceability matrix. Wrote and edited customer manual, service documents, installation & quick start documents in a highly regulated environment.Determined and develop solutions to technical problems related to quality and test insuring coverage and traceability.

Responsibilities

System level testing of embedded and application software, hardware electromechanical devices and the Verification and Validation testing of Gene Chip instruments, used to analyze complex genetic information for different industries: pharmaceutical, biotechnology, agrochemicals, academic, government to analyze the relationship between genes and human health.Integration testing to verify functional, performance and reliability requirements placed on major design items; including test method validation.Plan, design, develop and execute test cases for Instrument Control software, acceptance testing, ad-hoc testing, alpha testing, beta testing, black box testing, comparison testing, compatibility testing, end-to-end testing, exploratory testing, regression testing and functional testing.Test the application for reliability, safety, user error messages, and user friendliness.Develop new test procedures and modify existing procedures per current functionality.Identify System level failure modes (FMEA), assess risk, triage and corrective action preventative action (CAPA), analysis gage reliability & reproducibility (Gage R&R), and design of experiments.Assist Project Lead in System Quality Assurance and continue support until product release.Work in conjunction with Software Developers in an Extreme Programming environment.Recommend changes to instrumentation workflow and functionality.Work in all aspects of the software development life cycle.

Software Quality Assurance Engineer, Los Altos Software Testing, CA 2004-2008 Functional, Regression and System software testing of applications for complex devices. Manually Tested Net Accelerator Client application and Network Controller application on virtual machine connection. Wrote test plan and test cases for functional areas based on engineering specifications and requirements.Testing of software on medical patient monitoring GE Dash units and analytical chemistry A1c chromatography instrumentation.

Senior Software Test Engineer, Quality-Vectors Consultants, San Diego, CA 2003-2004 Contracted to Thermo Electron Fisher Scientific Instrumentation division

Wrote test plan and test cases for Quality assurance and Software testing of complex laboratory instrumentation (Mass Spectrophotometer) application program for the reporting of database data, graphical report charting, and user access security & user time stamping for 21 CFR part 11 compliance.

Manager Network Test Engineering & Field Service, SAIC, San Diego, CA 2001-2002

Contracted to California Department of Transportation Hands on Supervision, training & development of 12 field service network engineers in seven geographically remote laboratory facilities. Increased productivity nearly 100% while maintaining high quality levels.Developed and implemented test plans, requirements and procedures, reported status for the validation, operational, installation quality and of complex hardware communications instrumentation .

Senior Software QA Engineer, Oracle, Inc. acquired Portal Inc. Cupertino, CA 1999-2001Performed comprehensive Software Testing & support on a multi-tiered system Sun Solaris UNIX and Win OS platform. Software was a Web based: time, accounting billing, & merchant credit card application used in the telecommunications VOIP, On line Gaming, Internet Service Provider areas; with an Oracle database back end.Improved department’s productivity by balancing workload between four remote geographical offices.

Supervisor System Test & Manufacture, Tosoh Inc., Foster City, CA 1994-1996 Managed, planned, and organized activities of a team of System Quality Test technicians in the manufacturing test production facility and National & International Field Service Engineers.Performed QA Testing for firmware and applications software and writing final reports for Installation Qualification (IQ), and Operational Qualification (OQ). Created a quality and reliability improvement of 50% greater since assuming department responsibilities.

Sr. Systems Test Lead Syntex-Syva Instruments acquired by Roche, CA 1988 – 1993 Directed the activities of fourteen system test technicians in the manufacture and quality assurance of complex electro-mechanical Medical/Clinical Chemistry, Immunoassay, Drugs of Abuse Laboratory analyzers. Performed functional software, device validation and verification testing and Installation Qualification (IQ), and Operational Qualification (OQ). Reduced instrument qualification time by 50% while maintaining quality levels.

EDUCATION & PROFESSIONAL DEVELOPMENT

Bachelor of Science Electronic Engineering, CPU, Novato CA 1992

Associate of Science Electronic Engineering, Heald’s College, San Jose, CA 1985

2011 Certification, Six Sigma Green Belt, Expert Ratings, New York

2011 Certificate, Minitab Statistical Software, State College, PA

2011 Certification Six Sigma Lean, Expert Ratings, New York

2011 Certification, Total Quality Management, Expert Ratings, New York

2006 Certificate, Test Automation Software Tools, Portnov Computer, Mountain View, CA

2003 Certificate, Sun Solaris UNIX System Administration. Hello Computers, Santa Clara, CA

2003 Certificate, Software Validation & Verification, Santa Clara Technical, CA

2002 Certificate, Software Engineering, Quality Assurance & Testing, UC Santa Cruz, CA

2001 Certificate, Linux System Administration, Santa Clara, CA

1999 Certificate, Database Management and Concepts, SQL scripting, UC Santa Cruz, CA

1997 Certificate, Multimedia Design & Development, UC Santa Cruz, CA

1997 Certificate, Internet Web Administration, Golden Gate University, San Francisco, CA

PROFESSIONAL ASSOCIATION

Member American Society for Quality (ASQ)

Contact this candidate