1. Set up database for global regulations and standards and delivery key regulatory/standard updates regularly.2. Guide QMS improvement to achieve fully global compliance for 18+ oversea markets, including EU MDR certification transition.3. Organize regular internal audit to identify regulatory risk for oversea markets, including QMS risk and product compliance risk.4. Support audit response to the inspections from Competence Authorities, such as CE audit, FDA inspection, Ukraine factory audit, Kazakhstan factory audit, Brazil GMP audit, etc.5. Organize international regulatory training.

1. Overall responsible for compliance to ISO9001,ISO13485 and FDA QSR820.2.Lead QMS team, a strong team leader,especially for team motivation and innovation.3.Experienced project team leader,with successful project management experience for CAPA,documentation system transition,ISO9001/13485 new version transition.4.Good internal trainer,for Quality awareness set up,QMS relative standard/regulation and audit skill training and workshop organization. 5.Well knowledge for MDSAP.

1. Microbiology lab management and clean room environment monitoring. 2. NCR handle, conduct root cause analysis and CAPA follow up.3. Process control of sterilization and sterile product release.4. Supplier quality management and audit based on ISO9001, ISO13485.5. Project manager, closed projects including: -Mold contamination of clean room environment and products. -Process water contamination and water system improvement. -Bioburden repeat exceed the limits. -Bioburden test method optimize, reduce 50% cost. 6. Internal auditor for ISO13485, ISO9001, Medical device management regulation, with experience of FDA and DGM audit.

1. Manufacture Quality control and management.2. Raw material quality control and Laboratory management.3. Establishment, maintenance and continuous improvement of Laboratory Quality System according to the requirement of CNAS.4. Be responsible for QS certificate.5. Supplier assessment, audit and quality evaluation.6. Customer complains handling.

1. Core member of CNAS project team and do a good job for lab CNAS accrediation, the quality assurance laboratory of Amway was accredited as CNAS laboratory in the end of 2005.2. Be responsible for equipment management in Chemical and Microbiological laboratory.3. Conduct the microbiological and chemical analysis of raw material and finish goods of Cosmetic, Personal care and Home care products.

New products development of ELISA rapid Diagnostic Kit.