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 Expert  723197

Expert in Quality Assurance Engineering


Available for your Consulting and Expert Witness Needs

Nevada (NV)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, Design Reviews, Verification and Validation, Material Review Board (MRB), Risk Analysis, Project Teams and the manufacture of commercialized product. Additional activities included: parametric and non-parametric statistical analysis associated with Validations, Statistical Quality Control (SQC), Statistical Process Control (SPC) and Design of Experiments (DOE), creation of ISO9001/EN46000 and FDA cGMP compliant Procedures, Specifications and Work Instructions, Supplier Quality, Supplier selection and monitoring, customer return investigation and Corrective/Preventative Action (CAPA)

He has also provided Quality Assurance support for cross-functional New Product Development Teams, Project Teams, Material Procurement and Production to insure efficient development and commercialization of safe and reliable products. His activities included development, implementation and maintenance of ISO9001 and FDA (cGMP) compliant systems; creation of methods, procedures, specifications and instructions; maintenance of Material Review Board; Supplier Selection and Surveillance; Risk Analysis; internal and external audits and tool development. In addition, he provided statistical analysis and expertise to support Process Capability (Cp and Cpk) studies, Statistical Process Control (SPC), Design of Experiments (DOE); supporting Regulatory submissions and acceptance sampling.

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quality engineering

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quality evaluation

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quality standard

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acceptable quality level

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Current Good Manufacturing Practice

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design of experiments

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FDA medical device regulation

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Food and Drug Administration regulation

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ISO 9000 auditing

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medical device manufacturing quality control

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quality auditing

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quality control

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supplier quality assurance

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engineering quality assurance

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manufacturing quality assurance


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Reno, Nevada;  and Sparks, Nevada.

Education:
Year   Degree   Subject   Institution   Honors
1996   BS   Quality Engineering   La Salle University   Sigma Cum Laude
1993   AA   Quality Control   De Anza Colllege   Magna Cum Laude

Work History:
Years   Employer   Department   Title   Responsibilities

1998 to 2002

 

Medtronic Vascular

 

Quality Assurance

 

Senior Quality Engineer

 


1993 to 1998

 

Guidant Vascular

 

Quality Assurance

 

Quality Engineer

 


1992 to 1993

 

Sage Hill Engineering

 

Quality

 

Quality Manager

 

Responsible for all Quality related functions within a precision machining facility.


Career Accomplishments:
Associations/Societies

American Society of Quality

Licenses/Certifications

Certified Quality Engineer Certified Quality Technician


Consulting Services:
Selected Consulting Examples:
  • He assisted client in creating a ISO 13485 compliant Quality Management System
  • He developed client's in Business Plan, Marketing Plan and Quality Management System based on ISO 9002.
  • He developed a small manufacturing business including facility development, creation of specifications, procurement / manufacture of tooling and fixtures, and defining processes.
Recent Client Requests:
  • Expert for consulting on Need to draft and help implement GMP and QA programs...
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2003 to 2003   Canada   He provided expertise toward creation of a ISO 1348 compliant Quality Management System.

Language Skills:
Foreign Language  
English  

 

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