Senior SQE  New supplier evaluation, selection, qualification and audit, Leader auditor certification for ISO9001, ISO13485 and ISO17025 New component qualification following to Medtronic PPAP procedure. Familiar with the actual practice for control plan, PFMEA, MSA/GR&R, Capability study, Process validation (IQ, OQ, and PQ). Minitab study as the tool to analyze supplier process capability and online control. DRM Green Belt training is completed, one project are going for certification.  Supplier issue deal with and follow up, create SCAR to supplier for issue tracking, use 5-why, fish bone, pareto chart and some quality tools for root cause analysis. Supplier change control by SCR procedure accordingly. Supplier related SOP initial and update like supplier management, supplier performance review, supplier audit, supplier change control. Hold monthly SQE meeting, case sharing the actual practice and experiences with team.

Senior SQE Material quality assurance, focus on speaker, cable, die-cut and stamping, molding, painting and other electrical parts Supplier quality issue dealing with and solve, lead and coach supplier to improve their process quality, dig out the root cause and cut in the corrective action to reduce issue failure rate and avoid the issue duplicate, review 8D report New supplier survey and AVL supplier annual audit following to the ISO9001. New parts and second source qualification leader, co-work with PE to quality the part on line, request supplier following to Molex procedure and review the FAI, CPK, Flow chart, FMEA report and ect… In NPI stage, support RD team to do the risk assessment, request supplier to settle the key process stage, fasten the sampling inspection specification and frequency in Work Instruction; Co-work with QA team to fix the test jig both in Molex production line and IQC inspection stage.

SQE PM To be responsible for supplier quality management, successfully support 10 projects safe launch to RTS  New supplier survey in supplier side, Evaluates and reports quality effectiveness of new and potential suppliers, confirms ISO/TS-16949 compliance of supplier quality systems, processes, inspection, etc. Report to RD and Procurement related team for new resource balance. In NPI Stage, confirms and reports New Model Readiness for critical suppliers [spec review, lessons learned, Failure Mode and Effects Analysis (FMEA), Control Plan, initial parts verification, material certifications, Gauge Repeatability and Reproducibility (R&R)]. Arrange the Phase Gate review in every trial run stage. In NPI Stage, collect the data for supplier yield rate including input and output, establish supplier capability(including critical parameter and control plan for SPC Control in Ramp), make sure supplier can meet the shipment requirement, and high light to Procurement team or Project manager for any capacity issue if necessary. Raw Material issue handling, audit, audit and control supplier quality system, coordinator Quanta inner team to run MRB for urgent material or case, deal with the customer complain including external and inner(PD) on time, clarify the issue is design, process or material issue with related RD or PE member, request supplier to provide FA report (8D or 5C) within 3 working day. For Mass Parts, monitor critical supplier to cut in SPC control, coach supplier to create X-R control chart and control plan, settle the critical parameter and control point, implement the SPC Control in PD following to the request.