Expert Details
Quality Assurance Engineering
ID: 723197
Nevada, USA
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.
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 |
|---|---|---|---|
| Years: 1998 to 2002 | Employer: Medtronic Vascular | Title: Senior Quality Engineer | Department: Quality Assurance |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1993 to 1998 | Employer: Guidant Vascular | Title: Quality Engineer | Department: Quality Assurance |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| 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. |
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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
quality engineering, quality evaluation, quality standard, acceptable quality level, Current Good Manufacturing Practice, design of experiments, FDA medical device regulation, Food and Drug Administration regulation, ISO 9000 auditing, medical device manufacturing quality control, quality auditing, quality control, supplier quality assurance, engineering quality assurance, manufacturing quality assurance, product compliance, quality assurance engineering, medical device evaluation, Food and Drug Administration compliance, Food and Drug Administration validation, medical device inspection, Medical Device Reporting regulation, ISO 9004, medical device auditing, medical regulation, disinfectant Food and Drug Administration regulation, medical device product development, design-for-quality, biomedical instrumentation, disposable medical device, medical device product improvement, medical device manufacturing automation, pharmaceutical quality control, electronics manufacturing quality control, statistical quality control, medical device reliability testing, medical device process validation, medical device packaging process, medical device manufacturing, medical device design, Food and Drug Administration, design process, electronic medical device, biomedical device, medical instrument, biomedical instrument, medical device, Good Manufacturing Practice, Good Laboratory Practice, biomedical engineering