CURRICULUM VITAE
JOHN
SUZUKI
168 Chandon
Email:
URL: http://www.jksassociates.com
SUMMARY
Twenty four years of successful industrial experience in software development, software project management, software process improvement, software testing, software auditing, software project assessments, software quality assurance, medical manufacturing processes, medical computer software, systems engineering, medical device product development and diagnostics research and development; seven years of broad experience in academic laboratories in medical cardiovascular physiology, biochemistry, and organic chemistry. Unique combination of both practical and theoretical experience with good organizational and problem solving skills. Broad knowledge of product development strategies, manufacturing, team-based development and total quality management principles. Expertise in applying group facilitation techniques, people skills and systemic family therapy techniques to organizations and teams.
PROFESSIONAL
EXPERIENCE
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October 2007-Current |
Software
Consultant |
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Software Auditing, Verification and Validation |
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Software Project Management, Software Process |
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Improvement, |
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Software Retrospectives, Software Assessments. |
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Various medical, pharmaceutical, industrial, |
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and computer manufacturers in the Southern |
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Provides expert level consulting in
various software life cycle activities including
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July 2007-November 2007 |
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ComplianceOnline |
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Provided online, on-demand and web-based FDA
compliance and regulatory presentations and training to paying members and
member organizations that subscribe to the various services that the company
provides to the industry. Developed training materials for an
introductory
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December 2005-November 2006 |
Software and |
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RSI ID, Inc. |
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Cordis Division |
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Johnson & Johnson |
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Provided FDA compliance and
regulatory software consulting on software development activities that are
being used to develop software to control a cardiovascular stent automated
packaging system. Activities involved working with and assisting various
subcontractors and a software development organization with the system
development life cycle and assessing current software development practices
against Johnson & Johnson Corporate Validation practices. The scope of the
work included 21
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October 2006-December 2006 |
Software and |
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Software Verification and Validation |
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Intralase Corporation |
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Responsible for assisting in validation activities for a new 510k submission for laser control software. Activities included reviewing software and system requirements, development of system level test cases, development of and testing of new hardware test fixtures, and execution of system level integrated testing on a new laser system.
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August 2005-June 2007 |
Software and |
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AS-Software, Inc. |
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R&D Department |
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Provided compliance and regulatory software consulting on
internal QSR and software development activities that are being used to develop
software used for an obstetrics and gynecology ultrasound patient information
management system. Activities involved working with a consultant and the Software
Development organization and assessing current software development practices. Created
a Work Plan to bring the organization into FDA
The second phase involved developing documentation and
SOPs to meet the requirements for implementing a Quality System within the
organization. Consulting involved developing SOPs (internal auditing,
management review,
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July 2005-June 2006 |
Software and |
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NeuroComp Systems, Inc. |
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R&D Department |
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Provided compliance and regulatory software consulting on
internal QSR and software development activities that are being used to develop
software used to measure cognitive function loss from neurological degenerative
diseases such as Alzheimer’s disease. Activities involved meeting with Software
Engineering Departments and assessing current software development practices.
Created a
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January 2004-October 2004 |
Software and |
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Software Verification and Validation |
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Intralase Corporation |
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Responsible for validation activities for a second generation Class II ophthalmic medical laser to insure it meets the current FDA's Good Manufacturing Practices (cGMP's) and Quality System Regulations (QSRs). Responsibilities and work included:
· Co-wrote and reviewed the current Software Development Plan, Software Configuration Management Plan, and the Software Verification and Validation Plan for the software project.
· Co-wrote, developed, reviewed, and coordinated the Software Requirements documents.
· Co-wrote, developed, reviewed and coordinated the Software Architecture document.
· Co-wrote, developed, reviewed and coordinated part of the Software Detailed Design documentation.
· Developed code inspection process for safety critical source code modules. Led, participated in and trained development staff in formal code inspections (Ebenau and Strauss method).
· Developed and co-wrote the Software Traceability Matrix for the entire software system.
· Developed and wrote the all Software Testing Plans (Unit, Integration, System) for the project.
· Developed and wrote all Software Test Cases for systems testing on the project.
· Coordinated all verification activities with the Manager of Software Engineering and coordinated all validation activities with the Laser Physics, Electrical, Mechanical, Manufacturing, and Quality Systems staff.
· Performed state-of-the-art software systems testing on the hardware system and documented all test results. Developed and implemented corrective action process for software changes and software defects.
· Reviewed all software changes and software bug reports for systems testing.
· Developed and wrote the Software Testing Summaries, Software Problem Report Summaries, Release and Version Summaries and Software Certification for the system software.
· Acted as the Technical Software Consultant for Intralase for the entire project with regards to defining FDA compliant standards and internal processes during development and maintenance.
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September 2003-December 2003 |
Software
Consultant |
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Endocare |
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Regulatory Affairs Department |
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Provided compliance and regulatory software consulting on internal QSR and software development activities that are being used to develop control software for a next generation cyrotherapy medical device. Activities involved meeting with Quality, Regulatory Affairs and Software Engineering Departments and assessing current software development practices. Created SOPs, templates, forms and checklists for software development in order to meet FDA design controls, regulatory inspections, and risk management activities.
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March 2003-September 2003 |
Software and |
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NeuroComp Systems, Inc. |
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R&D Department |
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Provided compliance and regulatory software consulting on internal QSR and software development activities that are being used to develop software used to measure cognitive function loss from neurological degenerative diseases such as Alzheimer’s disease. Activities involved meeting with Software Engineering Departments and assessing current software development practices. Created a Quality System Manual and software development template for software development in order to meet FDA design controls and regulatory inspections.
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June 2003-December 2003 |
Quality
Management/Validation Consultant |
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Pfizer Global Research and Development (PGRD) |
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Quality Management Department |
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Provided full technical and regulatory validation support, technical leadership and process consulting for the entire Research Informatics organization (R&D) and for three business lines, which includes Pharmaceutical Sciences, Pharmokinetics/Dynamics/Metabolism, and Safety Science.
Provided internal consulting (software engineering,
quality management, GMPs, and regulatory compliance consulting) on several Ri
Informatics projects, including Watson LIMS (Laboratory Information Management
Systems), Xybion Pathology Toxicology System, Information Management System
(IMS), Citrix implementation of LabWare LIMS, Contracts Application Program,
Server Consolidation Project, Computerized Vendor Audits, and Part 11
Remediation Projects. Co-developed and led
Facilitated a Change Management session for DSi
organization during Informatics reorganization. Interviewed candidates for
business line scientific and computer positions using performance-based
behavioral interviewing techniques. Worked closely with QM colleagues at 4
other sites (
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November 2002-January 2003 |
Software
Validation Consultant |
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North American Scientific, Inc. |
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Automation GT, Inc. |
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Responsible for coordinating the software development life
cycle and validation activities for a new manufacturing
· Wrote, developed, planned and scheduled software quality assurance activities.
· Wrote and developed the current Software Verification and Validation Plan.
· Wrote, reviewed, updated and baselined the Software Requirements document.
· Wrote, reviewed, updated and baselined the Software Detailed Design document.
· Reviewed and baselined the Software Code document.
· Developed, documented, and reviewed the System and Software Safety and Hazard Analysis including software fault tree analysis and failure mode and effects analysis (FMEA).
· Developed, documented, and reviewed the Software Traceability of the system against the Software Requirements.
· Developed and wrote the Software System and Acceptance Testing Plans and performed state-of-the-art software testing on the system. Developed and implemented corrective action process for software.
· Performed physical configuration auditing of the software deliverables and software system.
· Acted as the Technical Software Consultant for North American Scientific, Inc. and Automation GT, Inc. for this project.
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July 2001-June 2003 |
Quality
Management/Validation Consultant |
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Pfizer Global Research and Development (PGRD) |
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Development Science Informatics (DSi) |
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Research Informatics (Ri) |
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Quality Management Department |
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Provided full technical and regulatory validation support,
technical leadership and process consulting for the entire Development Sciences
organization (R&D) and for three business lines, which includes
Pharmaceutical Sciences, Pharmokinetics/Dynamics/Metabolism, and Drug Safety
Evaluation. Participated in a site wide PGRD 21
Provided internal consulting (software engineering, quality management, GMPs, and regulatory compliance consulting) on several DSi/Ri Informatics projects, including LabWare LIMS (Laboratory Information Management Systems), Chromatography Data System (Waters Millennium 4.0), SSI Cyberlab 2.1 data archive, Blue Mountain Calibration Manager, Batch Record Systems, Clinical Material Tracking system, Import/Export application, Peoplesoft Material Management ERP application, Business/Financial Records systems, Investigational Sciences Database, Global Scientific Warehouse, SOP documentation system, and a Training Management (Click2Learn) system.
Assisted in building, organizing and staffing the DSi and
Quality Management organization within Informatics. Served as acting QM manager
responsible for 1 employee, 3 contractors and 1 consultant. Activities included
providing GxP training, writing departmental and Quality Management SOPs,
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July 2001-July 2001 |
Consultant |
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Compass Limited Corporation |
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Responsible for providing training and consulting on 21
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February 2000 - December 2003 |
Software and |
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Software Verification and Validation |
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Intralase Corporation |
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Responsible
for coordinating the software development life cycle and validation activities
for a new Class II ophthalmic medical laser to insure it meets the current FDA's
Good Manufacturing Practices (cGMP's) and Quality System Regulations (QSRs).
Company passed a FDA and California State Health Department facility inspection
and design control audit based on supplied deliverables, and the activities and
processes utilized as part of my consulting. As a result, the Company received
a certificate to sell its medical device in the State of
· Estimated, developed, planned and scheduled software development and validation activities using parametric cost and estimating software programs (Estimate, COCOMO II and Microsoft Project 98).
· Co-wrote and reviewed the current Software Development Plan, Software Configuration Management Plan, and the Software Verification and Validation Plan for the software project.
· Co-wrote, developed, reviewed, and coordinated the Software Requirements documents.
· Co-wrote, developed, reviewed and coordinated the Software Architecture document.
· Co-wrote, developed, reviewed and coordinated part of the Software Detailed Design documentation.
· Developed code inspection process for safety critical source code modules. Led, participated in and trained development staff in formal code inspections (Ebenau and Strauss method).
· Developed, analyzed, revised and documented the Software Safety and Hazard Analysis including fault tree analysis and failure mode and effects analysis (FMEA) utilizing ISO 14971 (Medical Device Risk Management Standard).
· Developed and wrote the Software Traceability Matrix for the entire software system.
· Developed and wrote the all Software Testing Plans (Unit, Integration, System) for the project.
· Developed and wrote all Software Test Cases for all levels of testing on the project.
· Coordinated all verification activities with the Manager of Software Engineering and coordinated all validation activities with the Laser Physics, Electrical, Mechanical, Manufacturing, and Quality Systems staff.
· Performed state-of-the-art software testing on the GUI interface and hardware system and documented all test results. Developed and implemented corrective action process for software changes and software defects.
· Reviewed all software changes and software bug reports.
· Created and developed software metrics for the entire project.
· Developed and wrote the Software Testing Summaries, Software Problem Report Summaries, Release and Version Summaries and Software Certification for the system software.
· Performed and documented both physical and functional configuration audits on the software system and development process before release.
· Acted as the Technical Software Consultant for Intralase for the entire project with regards to defining FDA compliant standards and internal processes during development and maintenance.
· Developed and carried out a Project Post Mortem and Project Retrospective after the completion of the project.
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May 2000-October 2000 |
Software and |
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LifetecNet.Com |
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Provided software project consulting to insure that the new business-to-business (B2B) electronic commerce Web site would meet Food and Drug Administration (FDA) Pharmaceutical and Medical Device Current Good Manufacturing Practices (cGMP’s). Responsibilities included creating a project software development plan, project software configuration management plan, and project software quality assurance (validation) plan for the Web site and integrated third party applications. Also, provided a standard operating procedure (SOP) for a specific regulatory procedure. Provided feedback and expert opinion on architecture, design, design control, coding, testing, traceability and version control practices and documents for the project. All project consulting was provided virtually.
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March 2000-April 2000 |
Software
Consultant |
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Warner Bros. |
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New International Television Division |
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Management Information Services |
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Provided a project assessment of the first phase of a 4-tier Client Server, Java-based, worldwide Intranet application for the New International Television Division. The project assessment covered the development and quality assurance organizations and culminated in a 28 page assessment report with an implementation plan for suggested project improvements. Activities included interviewing project management, developers and support staff for the project and reviewing project processes and documentation. The assessment also included an evaluation of the human aspects of development and recommendations for improving speed for delivery.
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December 1998-June 2000 |
Software
Consultant/ |
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Xerox Corporation |
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Printing Systems Group (PSG) / Production |
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Controller Development Team (PCDT) |
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Responsible for assisting in the
setting up of a
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October 1999-December 1999 |
Consultant |
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Operations Department |
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Alcon Surgical, Inc. |
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Provided validation consulting for a medical ophthalmic ultrasound
measuring device. Responsibilities include writing plans, procedures, and
validations; and performing reviews and statistical tests to support the FDA
Current
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April 1998-October 1998 |
Software
Consultant/Software Lead Tester |
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Corporation |
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Responsible for test planning, test schedule development, test
progress reporting, unit and integration testing of an add-on module for
Also responsible for assisting in the set-up of a configuration
management system (Implementer by
Silvon) for a commercial banking package, Silverlake.
Technically responsible for testing various aspects of the transaction-based
banking and loan package which will interface with the
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December 1996-April 1998 |
Consultant |
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Software Verification and Validation |
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Ismecam, Inc. |
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Responsible
for managing and coordinating the software quality assurance activities with
Integ, Inc. of
· Wrote, developed, planned and scheduled software quality assurance activities.
· Wrote and developed the current Software Verification and Validation Plan.
· Reviewed, updated and baselined the Software Requirements documents.
· Reviewed, updated and baselined the Software Detailed Design documents.
· Reviewed and baseline the Software Code documents.
· Developed, documented, and reviewed the Software Safety and Hazard Analysis including software fault tree analysis and failure mode and effects analysis (FMEA).
· Developed, documented, and reviewed the Software Traceability of the system against the Software Requirements.
· Developed and wrote the Software Testing Plans (Unit, Integration, and System) and performed state-of-the-art software testing on the system. Included Year 2000 assessment, planning, testing and compliance. Developed and implemented corrective action process for software.
· Created and developed software metrics for the validation and testing.
· Performed physical configuration auditing of the software deliverables and software system.
· Acted as the Technical Software Consultant for Ismecam, Inc. and Integ, Inc. for this project.
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Sept 1997-Nov 1997 |
GLP/ |
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Consolidated Laboratory Services |
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Provided consulting in the Good Laboratory Practices
(GLPs) and Good Manufacturing Practices