>Define the inspection process of the whole process, include the process inspection &outgoing inspection>Timely setting quality meeting to review the customer’s compliant and feedback ,drive team to continue improvement>Working with the R&D design team to improve the manufacturing process and customer end quality improvement and develop improvement plans >Develop assessment objectives for Quality Engineers and technicians>Regularly summarizes the work plan with… Show more >Define the inspection process of the whole process, include the process inspection &outgoing inspection>Timely setting quality meeting to review the customer’s compliant and feedback ,drive team to continue improvement>Working with the R&D design team to improve the manufacturing process and customer end quality improvement and develop improvement plans >Develop assessment objectives for Quality Engineers and technicians>Regularly summarizes the work plan with team members>Working with cross function team to define the process flow>Regularly organizes the quality meeting with the production team to review process quality and customer quality issues and make the improvement plan>Work with SQE to conduct quality audit to potential new suppliers or regularly supplier audit.>Root cause analysis with supplier and verify effectiveness of the CA/PA which suppliers take.>In process quality control and final quality control in supplier site during the engineering sample and FA sample phase of PCBA. Show less

>Responsible for driving products improvement in operations quality which with diagnostic imaging medical device(CT,PET CT) to ensure meet the all KPIs. >Responsible for planning execution and review of TMV(test method validation) and coordinate with ME for PV( process validation ) activity including IQ,OQ,PQ. >Responsible for handling and determine nonconforming products or materials. >End to End quality management experience with NPI,Design Transfer, Manufacturing… Show more >Responsible for driving products improvement in operations quality which with diagnostic imaging medical device(CT,PET CT) to ensure meet the all KPIs. >Responsible for planning execution and review of TMV(test method validation) and coordinate with ME for PV( process validation ) activity including IQ,OQ,PQ. >Responsible for handling and determine nonconforming products or materials. >End to End quality management experience with NPI,Design Transfer, Manufacturing Transfer, Prodution&Process control, Process validation.>Passed certification of Quality system ISO13485 by TUV-SUD>Familiar with APQP when submitted the product /material to sister site.>Participate and supporting external audit(FDA,MDSAP,EUMDR,CFDA...) and internal audit. >Supporting CAPA's investigation and action follow up,and Compliant handling and Deviation or concession process . >Certificate with GB9706 inspector by Suzhou external training. >Participate the EUMDR project to ensure the manufacturing process fully compliance the EU MDR requirement with successfully.>Take role as MQ for NPI or NPT project transfer and drive the quality improvement in PV stage.>Lead OPS team for yield improve and achieved PEC(Philips Excellence Competition ) award with second place.>Excellent award and spot awards in Y2020. Show less

>Initiate continuous improvement plan by weekly review the quality issue with CFT team.(RTY, Component defect rate, Quality Metrics).>Formulate internal process audit plan and check list to make sure internal process execution and improved weakness by PDCA, so that meet the customer annual audit expectation and all non-conformance should take action.>Actively coordinate the CFT team to pass customer’s annual audit and continual improvement.>Lead the CFT team to achieve… Show more >Initiate continuous improvement plan by weekly review the quality issue with CFT team.(RTY, Component defect rate, Quality Metrics).>Formulate internal process audit plan and check list to make sure internal process execution and improved weakness by PDCA, so that meet the customer annual audit expectation and all non-conformance should take action.>Actively coordinate the CFT team to pass customer’s annual audit and continual improvement.>Lead the CFT team to achieve the ESD class0 project in Suzhou and get the customer’s appreciation.>Working together with PM to define the traceability process and control point.>Tracking the quality performance of NPT/NPI product and previous prepare, weekly conference call with customer USA team for engineering &quality issue.>Participate Lean/Kaizen projects with operation team to continue improving process.>Utilize the SPC tool to monitor the SMT/AOI/5DX/ICT performance，push related owners to take actions accordingly. Show less

>Interface with customer on their quality, product & process requirements.>Generate the quality procedure, instructions, checklist and training the QA for audit skill.>Weekly review with customer for product yield&defects and provide the solid action.>Handle the quality issue from production line&IPQA’s findings, Escalate the issues if some have high potential risk or high risk.>Instruct the IQA for incoming inspection to meet the C=0 sampling check plan… Show more >Interface with customer on their quality, product & process requirements.>Generate the quality procedure, instructions, checklist and training the QA for audit skill.>Weekly review with customer for product yield&defects and provide the solid action.>Handle the quality issue from production line&IPQA’s findings, Escalate the issues if some have high potential risk or high risk.>Instruct the IQA for incoming inspection to meet the C=0 sampling check plan requirement.>Publish the IQA non-conformance issues to buyer&SQE for further disposition.>Involve SQE/PE/QE/Production/Buyer to weekly review the MRB inventory. Show less