ISO EXPERT WITNESS

EDUCATION

BSEE + 47 post graduate units, San Jose State University
Business Administration 3 years, University of Nebraska, Lincoln, NE

EXPERIENCE

1998-Present, Principal, Expert 1794's Enterprises

Quality Assurance Consultant, Surgrx, Palo Alto. Mfr. of tissue sealing device
Revised company QA procedures to be in compliance with ISO 13485:2003

Quality Assurance Manager, DC Valve, San Jose. Precision Machine Shop
Established ISO 9001 compliant QA System

Tecan Systems, San Jose Mfr. Of OEM medical devices
Performed internal audits of ISO 9001 quality system.

American Society for Quality
Coordinated curriculum of 16 biomedical classes

QA Consultant, Surgrx, Palo Alto. Mfr. of tissue sealing device.
Wrote design/process validation protocols, performed verification and validation testing.

QA Consultant, Curon Medical, Sunnyvale. Mfr.Of esophageal catheter.
Prepared, on time and under budget, semi annual supplier performance report.

RA Consultant, Pulnix, Sunnyvale, Mfr. of laser and medical laser products.
Prepared, on time and under budget, Annual Reports, and other regulatory reports for the Center for Devices and Radiological Health (CDRH)

QA Consultant, Powderject Technologies, Fremont. Mfr. of through the skin vaccine injector.
Managed the review and approval of batch records. Wrote and revised QA procedures.

QA Manager, Enteric Medical, Foster City. Mfr. of esophageal catheter.
Led the effort to (1) successfully implement (from scratch), and maintain an ISO 9001/QSR program (2) meet the biocompatibility requirements for the company's product (3) successfully complete the sterilization validation process, and implement the sterilization program. Managed the document control function.

Sr. Quality Engineer, Conway-Stuart Medical, Sunnyvale (Mfr. of electro-surgical devices)
Successfully developed and implemented sterilization plan in compliance with AAMI, FDA, ASTM, and other related standards. Coordinated completion of the dose mapping process, the Eto and e-beam sterilization validation process, and the accelerated aging process, Led the effort to complete the bioburden count, verification dose experiment, and the sterility testing processes.

1996 to 1998, Manager, Regulatory Affairs and Quality Assurance, RITA Medical Systems, Mt. View (Start up mfr. of electro-surgical devices)
Implemented and audited QA program in compliance with ISO 9001 and QSR's. (On time and under budget), Implemented sterility assurance program including quarterly bioburden and environmental monitoring, radiation dose verification per AAMI 13409, package integrity testing, and accelerated aging, Worked closely with engineering, clinical research, and production in the continuing development of new products and their transfer to manufacturing, Wrote audit procedure, performed internal and vendor audits to assure conformance to ISO and QSR requirements, Handled complaints, wrote and processed MDR's. Responsible for incoming, in-process, and final inspections. As safety officer, developed blood borne pathogen exposure control program.

Senior Quality Engineer
1992-1996, Advanced Cardiovascular Systems, Santa Clara, (Mfr. of catheters and stents)
1992, Laserscope, San Jose, (Mfr. of laser surgical instruments)
1990-1992, Computer Products, Fremont, (Mfr. of computer power supplies)
Supervised QC techs, inspectors, and calibration lab technicians. Developed QA plans and inspection plans that aided in the early releases of new products at lower cost, Performed process qualifications and validations, including required testing, and prepared corresponding reports. Used statistical techniques to derive most economical sample sizes and evaluate test results, Established and maintained quality training programs and trained engineers in SPC, FMEA, reliability, probability, quality costs, good manufacturing practices, standard operating procedures. Received positive feedback on quality of training, Introduced and maintained a statistical quality control program in the inspection and production departments that substantially reduced defect rate.

1985-1990, Product Assurance Auditor, United Technologies, San Jose, (Mfr. of rocket motors) Performed quality audits of the 24 elements of the company's MIL-Q-9858 quality program, one result of which was improving the company training program by adding exams and instructor evaluations to it.

SUMMARY

Expert 1794 is a tenacious, follow-through quality assurance and regulatory affairs professional with over 15 years of quality management, engineering, auditing, and regulatory affairs experience in medical device firms.

Expert 1794 demonstrated strengths in planning, organization, problem analysis and resolution. Extensive experience in establishing and auditing quality assurance programs, in compliance with FDA, Canadian, European, and Japanese requirements. New product introductions, interface with the FDA. Expert 1794 has heavy experience in ISO 9000 and GMP/QSR implementation and auditing. Expertise in statistical process control, procedure writing, (including procedures in compliance with 13485:2003) quality training, auditing, inspection support, and non-conforming material control. A high energy, proactive contributor to bottom line profit by the dedicated use of quality management tools and programs. Taught QSR and other classes for American Society for Quality.

AFFILIATIONS

American Society for Quality: As chairman of San Francisco section, won award for best managed section in the country by diligent follow up of all programs administered by the section.

KEYWORDS

ISO 9001 Expert Witness, ISO 13485 Expert Witness, ISO 13485:2003 Expert Witness, QSR Expert Witness, Auditing Expert Witness, Quality Engineer Expert Witness, Quality Manager Expert Witness, Procedure Writing Expert Witness, CE Marketing Expert Witness, Quality System Regulation Expert Witness, Planning Expert Witness, Organization Expert Witness, Problem Analysis Expert Witness, Statistical Process Control Expert Witness, Training Expert Witness, 501K Expert Witness, Council Directive 93 42 EEC. Process Validation Expert Witness, Complaint Handling Expert Witness, AAMI 13409 Expert Witness, Interface with FDA Expert Witness

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