James Yen

Quality Management Systems 27 years of managing (1995 - 2023) Quality Management Systems Audits in suppliers, subcontractors, customers, internal and certification audits. Collectively for 9 years, (2010 – 2018), ran successfully the World-Wide Global Audit Programs (WW Customer audits, WW subcon and supplier audits, WW certification audits, WW internal audits) for Micron. Successfully completed setup, lead all Micron sites to their ISO 9001 and IATF 16949 certification. These included all existing or new manufacturing facilities; design centers; sales and marketing, all supporting processes and organizations at Micron. A qualified Lead and Principal Quality System Auditor for ISO 9001 with IRCA from 1997 – present. Understand widely the application of QMS tools such as FMEA; QCP; PDCA; 8-D; MSA; Change Controls; Internal Document Controls; Calibration; ESD; and other process requirements. A subject matter expert on Quality Management Systems for ISO 9001 and IATF 16949 at present. Past experience included setting up the internal audits for previous standards that included both ISO 14001 and OHSAS 18001. A successful QMS trainer with clear explanation to implementers at WW sites. A Lead SQA Assessor with Spring Singapore (1998 – 2010) for the Singapore Quality Award (SQA) Assessment framework. A clear understanding of the SQA requirements having been involved in assessments on winning organization (i.e., PSA, Citibank, Subordinate Court, ITE, Nanyang Polytechnic, and Teck Wah). Invited Guest Speaker relating to ‘Processes and Customers’ for Business Excellence for Spring Singapore in April 2007 at SUNTEC Convention Center. Quality Operations 24 years’ experience in running QA Operations (1992 – 2010 and 2018 - 2023) covering IQC, Assembly and post assembly in-process controls, Test burn-in and electrical lot accept, package reliability lab, outgoing and line pack lot accept. Exposed to the whole plant operations and systems both at Texas Instruments and Micron (Assembly, Trim and Form, Test, Backend, Line-pack, Shipping, Reliability, Training, Calibration, suppliers/subcontractors audit, document control, and Incoming Quality Control). For the period (2018 – 2021), successfully lead 4 manufacturing sites in Asia involving a team of over 100 managers and engineers and integrated and aligned its processes and documentation practices. These processes included plant and maintenance, process and sampling plans, charts, and operations procedures. A total of 1500 procedures were obsoleted, and a common based procedure were documented with all sites.