Ensures new component approval process is established and followed, which also includes changes. Drawing review. First article and Sourcing inspection activities. Product veri cation. Coordinate and distribute supplier re-quali cation, with improvement plans as determined required.: ISO 9001 & IATF 16949  process audit. Conduct on-site supplier audits Ensure e ective corrective, preventive actions are obtained for any supplier quality issue. Working knowledge of injection, welding, soldering, and assembly procedures and tools.

 Global training system project leader, responsible for global training system.  Managing global administrators and driving continuous improvement plan.  Implementing software UI/UX from original concept through to final implementation.  Integrated system: badge reader system and offline training system.  Continuous quality improvement project cooperate with US & NL function team.  QA testing for 30+ electronic forms and review the processes meet SOP / WIP.  Supplier product change request process improvement.  Conducting QMS internal & spot audit and reporting to top management.  Audit purchasing process, supply chain procedure, and product development.  Working knowledge of ISO 9001/13485/14001/RBA etc.  Conduct 33 ISO committee to get ISO certificate

 Lead product FAI, product verification & validation during the NPI stage.  Knowledge of IATF 16949 5 Core Tools (APQP, PPAP, FMEA, SPC and MSA.)  Internal lecturer: Product verification and validation plan trainer.  Review Product drawing, DHF, DHR, and DMR with IEC and ISO requirements. Released & go mass production  2 electrosurgical pencils (invasive surgery products & got 510K).  3 return pads. (Review GD&T and can understand drawing)  3 AED accessories to mass production.  Customer complaints and root cause analysis.  Identify quality issue, drawings review,and communicate with R&D and supplier.  COPQ project slashed costs by 10% in 4 months.

 Implement an ISO standard and SA8000 in TW and China factory.  Cooperate with Dept. Leaders to certified ISO 9001 & SA8000.  Arrange internal audit and external audit.  Ensure standards, procedures, CAPA, effectiveness are being followed.  Quality Manual, Procedure, and SOP maintenance and up-to-date.  Review documents and prepare training materials.

 Coordinate with customer to comply with the ISO 28000 standard and AEO certification  Audit logistic system for supply chain security and review document to meet AEO.  Train and review logistic risk assessment.