Invited to participation the new management team in early 2022 to lead the rebuilding of the company's quality policy, quality objectives and product risk management as below, 1. Lead QA team modified Quality Manual to meet ISO 13485, MDR and regulation requirements. 2. Successful completion of TFDA QMS review and ISO third party survey. 3. Improve the Post market survey process to ensure consumer experience data collection and future NPI development reference follow up. 4. Re-establish the ECR/ECN process to ensure that the evaluation and validation process meets QSR, MDR, and ISO system requirements. 5. Manage wavier issue verify to make sure product quality complies, and create consumer feedback questionnaire to ensure that information which CAPA respond can be stored and transfer to opportunity for next generation product series fix. 6. Acting as group management representative and board of directors to make suggestions and proposals for future automation, such as AOI system application, automated equipment validation program and automation quality process build up.

1. Assist CEO in setting up document traceability system. 2. Direct the development of medical business units. 3. Direct internal 13485 quality training. 4. Redesign and establish supplier evaluation platform.

1. Managed ISO 13485 and monitored internal audit operation. 2. Leaded TQM activity and CIP project. 3. Planed NPI Validation Strategy. 4. Evaluated New Supplier Qualification & Monitored Supplier Quality Activity. 5. Motivated Process Re-Validation Protocol and Implementation. 6. Monitored Production Quality implementation and control. 7.Lead CAPA Investigation & Redesigned Verification of Preventative Action. 8.Qualified Lecturer of Quality System Training.

1. Managed ISO 9001 and Monitored Internal Audit Operation. 2. Leaded IATF16949 Risk Evaluation & Implementation. 3. Planed SQM Strategy and Annual SCM Audit. 4. Evaluated PPAP Submission. 5. Review & Negotiate Quality Agreement. 6. Monitored E-Data Collection & MES System Built. 7. Reviewed SPC Trend & Control Limit. 8. Designed and implemented New BU’s Product Development Map & Validation Flow.