Expert Details

Expert in Quality Assurance Engineering

Expert ID: 723197 Nevada, USA

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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 (Expert), 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.


Array

He assisted client in creating a ISO 13485 compliant Quality Management SystemHe 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.

Expert may consult nationally and internationally, and is also local to the following cities: Reno, Nevada - Sparks, Nevada

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Education

Year Degree Subject Institution
Year: 1996 Degree: BS Subject: Quality Engineering Institution: La Salle University
Year: 1993 Degree: AA Subject: Quality Control Institution: De Anza Colllege

Work History

Years Employer Title Department Responsibilities
Years: 1998 to 2002 Employer: Medtronic Vascular Title: Senior Quality Engineer Department: Quality Assurance Responsibilities:
Years: 1993 to 1998 Employer: Guidant Vascular Title: Quality Engineer Department: Quality Assurance Responsibilities:
Years: 1992 to 1993 Employer: Sage Hill Engineering Title: Quality Manager Department: Quality Responsibilities: Responsible for all Quality related functions within a precision machining facility.

International Experience

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

Career Accomplishments

Associations / Societies
American Society of Quality
Licenses / Certifications
Certified Quality Engineer
Certified Quality Technician

Language Skills

Language Proficiency
English

Fields of Expertise

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