Simon Nguyen

Experience

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  KAO Infosystems, Inc.

  May 1996 - Apr 1997

  Manufacturing Engineer

  • Cut the production cost in half over the time frame of 3 months and set a new quality production standard.• Increased the production output from 2000 pieces in an 8-hour shift to 12,000 pieces in an 8-hour shift, a 500% increase of productivity• Developed the training system for all the machine operators.• Standardized the production flow process and approved for ISO 9001.• Utilized the JIT systematic and SPC to control the high output of production and yield

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  Olympus America Inc.

  Apr 1997 - Jun 1998

  Quality Assurance Engineer

  • Conducted failure investigations of the nature of the endoscope's nonconforming.• Recommended and implemented the improvements in the later generation of the endoscope products.• Developed regular trending and reporting of quality data • Reviewed data of all nonconformances in all aspects of the production • Evaluated the filing system software for the Regulatory Affairs purpose.

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  AdForce Inc.

  Jun 1998 - Jun 2001

  Network Administrator

  • Provided day-to-day support for all IT including desktop support, troubleshooting any IT problem, maintaining and upgrading inventory of hardware and software• Managed company's LAN/Wan networking, print/file servers, RAS servers, FTP servers, DHCP/Wins servers, Exchange 5.5 server, QA intranet/ streaming servers, and BDC servers.• Supported audio/video conference, PDA i.e. Palm Pilot, Handspring, RIM• Provided technical, operations and training support to users of company's personal computers either by telephones or on-site • Performed hardware diagnostics and coordinated repairs with OEM Show less

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  Olympus America Inc.

  Jan 2002 - Jan 2009

  Quality Assurance Engineer

  • Conduct periodic product, process and systems audits and support preventative and corrective action activities and ensure that specified requirements are met; conducted internal audits in the field• Investigate quality discrepancies and determine final disposition of discrepant material and finished product and assign responsibility• Initiate corrective and preventative action activities and Corrective Action Report generation related to quality problems based on frequency and severity.• Support and provide final quality judgments, standard interpretation and applicability.• Analyze service records with appropriate statistical methodology in support of tracking and measuring the quality of service / repair from a QCD perspective.• Develop and maintain regular quality trend reporting and analysis in support of user claims on products within warranty period, also known as Warranty Rate reporting Show less

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  Olympus Corporation of the Americas

  Jan 2009 - Oct 2019

  Sr. Regulatory Affairs Engineer

  Currently working as Sr. Regulatory Affairs Engineer in Regulatory Affairs department in charge of all potential quality issue investigation of endoscopic products. Successfully supported validation processes, reviewed and updated departmental documentations, and conducted training programs of two different complaint systems to the production and RA departments: SAP and EtQ.• Conducted failure investigations of the nature of the endoscope's nonconforming.• Recommended and implemented the improvements in the later generation of the endoscope products.• Developed regular trending and reporting of quality data • Reviewed data of all nonconformances in all aspects of the production Show less

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  Olympus Surgical -OSTA

  Apr 2017 - Oct 2019

  Market Quality, Supervisor of Engineers
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  Olympus Surgical Technologies Americas

  Oct 2019 - now

  Associate Manager