Bio
Credentials
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Regulatory Affairs Certificate: Medical Devices
Regulatory Affairs Certification ProgramJun, 2022- May, 2026
Experience
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Director, Quality Management System
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Feb 2023 - Present
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Manager, Quality & Doc. Control
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Mar 2018 - Mar 2023
Manage Quality Assurance objectives; NCMR, CAPA's, Internal/External Audits and Training Compliance.International documentation for government bodies; Certificate to Foreign Government.
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QA Change Analyst
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May 2015 - Mar 2018
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Thermofisher Scientific
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Sunnyvale, CA
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Designer
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May 2014 - May 2015
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Sunnyvale, CA
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Varian Medical Systems
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Palo Alto, Ca
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Mechanical Designer V
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Mar 2013 - May 2014
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Palo Alto, Ca
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Velodyne Lidar, Inc.
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Morgan Hill, CA
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Document Control Specialist
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Mar 2012 - Mar 2013
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Morgan Hill, CA
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Philips Healthcare
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San Jose, CA
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Engineering Services Supervisor
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Apr 2001 - Mar 2012
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San Jose, CA
• Manage the workload of the drafters and designers to support new product introduction, cost reduction, and manufacturing efforts to meet the organizations objectives.• Responsible for supporting work requests from field service, manufacturing, suppliers and engineering for multiple business locations (San Jose, Cleveland, Mexico and China).• Delegate and complete drafting requests, BOM structure and changes, and new design documentation for ECO release using Agile PLM.• Generate technical work instructions for Solidworks users for installation, upgrades and troubleshooting.• Provide written and verbal updates to senior staff and program managers on the status of ECO documentation changes.• Evaluate and select tools to ensure best practices are applied to 3D solid modeling, drawings, and database management to improve the CAD group.
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SolidWorks Instructor
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Aug 2006 - May 2007
• Solidworks evening instructor for a technical trade school.• Generated all lecture material, lab assignments, student syllabus and modeling demonstrations for class instruction.• Maintained attendance logs to meet training requirements for student certification.• Maintained classroom setting with system maintenance (software updates). Generated tests and quizzes for student development.
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Sr. Designer Drafter
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Mar 1996 - Apr 2001
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Milpitas
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CAD Drafter Detailer
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Aug 1992 - Mar 1996
• Responsible for detailing production parts and implementing (ECO’s/ECR’s) engineering change orders and change requests.• Worked close with engineers to document assembly procedures and test fixtures for production release.• Generated all documentation required to procure fabricated parts for prototype designs.• Generated detailed instruction manuals using CAD illustrations for assembly process.• Participated in the ISO certification process by generating department (SOP’s) Standard Operating Procedures and workflow diagrams to meet audit requirements.
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Education
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2009 - 2011Ashford University
Bachelors of Arts, Organizational Management -
Nx Rev
Wildfire 4.0 Certificate, Intro to ProEngineer -
GEI Technology
SolidWorks Certification -
1991 - 1993Masters Institute
Associate of Science, Electrical & Mechanical Design Drafting -
Central County Occupational Center
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