-Responsible for and supervising supplier and internal QMS audit, client questionnaire, and CAPA.-Maintain QMS and valid GMP/ISO 13485 certificates.-Assist and follow up CAPA to close.-Perform internal quality training.-Standard Operation Procedure management, issuance, and archive.-Master Batch Record Management.-Documentation and record management.-Monthly products quality and warehouse environment monitoring data collection.

-Regulatory Auditing of Quality Management System for medical devices imported.-Execute external audits and monitor quality related operations for continuous quality improvement (Taiwan GMP, which's compliance with ISO 13485:2016). -Monitor and follow up on CAPA to ensure complete closures and effectiveness for manufactures. -Monitor manufacture’s and pharmaceutical firm's compliance with the laws and regulations governing product quality assurance. -Serve as the main contact person with the regulatory affairs in manufactures, pharmaceutical firms and other organizations. -Provide monthly status report of approved manufacturing and importing medical devices firms. -Be responsible for noticing local medical devices complaint as well as medical device regulatory reporting. -Communicate with complaint reporter to address critical controversial regulations.-Generate QMS application electronic system-Maintain international cooperation project and plan the budgets, including: Europe (TCP) and Japan.

-Assisting preparation of submission package/ conduct feasibility/ Review Protocol and design informed consent form (ICF)/ PI meeting/ recruit patients/ routine monitoring/ SDV/ perform Case Report Forms (CRF) review and site close out/ data analysis and clinical study report for certification and so on.-Serve as the primary contact with individual investigative sites and member training. Monitor the assigned study sites following company SOPs in accordance with GCP. Ensure site members compliance with the study, overall clinical objectives and regulations.-Clinical study materials management. Independently perform Case Report Forms (CRF) review. Finish data analysis and clinical study report for certification.