Company profile：WOFE American company to produce medical devices for WWTitle：Quality & Technical Consultant, then Supply Chain Manager Reporting line：President Subordinates：3Responsibilities：To build up all the quality for medical devices realization, to make product specimen for qualification & evaluation, systematically establish the documents to meet ISO 13485 & ISO 9001 and MDD (Medical Device Directives) requirements.To establish the purchase channels for all outsourcing & sourcing materials from worldwide for our localized medical devices manufacturing in China facility for which Scion purchased & transferred the MDs from USA & France and integrated all productions in China, and now we are going to localize some of materials to be more competitive to markets. To maintain the test relationship with SGS & local testing institutes to test & register our medical devices.Achievement：Successfully established the purchase channels for all materials and met the requirements for production demands and now being moved forwards.

Main Responsibilities & Performances:1. Work with product management, supply chain/plant purchasing or field marketing to establish technical specification.2. Supplier outsourcing and qualification in China and Asia.3. Supplier management including quality control, performance evaluation and preparation of proposal.4. Support global supply chain or purchasing in price negotiation with the identified suppliers.5. Prepare and present relevant proposals to senior management6. Work with suppliers to implement continuous improvement and cost reduction programs.7. Audit suppliers to insure Quality Systems consistently meet performance requirement8. Coordinate with supplier to insure Entegris customer specific requirements are understood and met9. Work with Entegris Customer Service to prioritize supplier workload when required10. Work with Logistics team to establish the right route to deliver products with lower cost11. Support local sales to develop & maintain the continuous businesses in China.

Joined TUV Asia Pacific (Shanghai) Ltd. as a auditor for medical devices in August, 2001, systematically got sufficiently related training on ISO 13485, EN 46001 and MDD (Medical Device Directives) requirements and certified for practical auditing, I had successfully been qualified as a Lead Auditor.

In Millipore Suzhou, I took manager duties of quality assurance, product technology, CSS (customer satisfaction service) and supplier qualification/evaluation. I was responsible for building quality management system for filter production, also for stainless steel filter housings for assembling filter cartridges which had been positioned in pharmaceutical and medical device manufacturing. I had more experiences of quality system, product specification preparation, qualification / validation, production operation, training skills and continuous improvements.Millipore Suzhou was ISO 9002 certified company & I was management representative. I took the duties to prepare this project starting from our documentation. Company passed successfully the assessment and certified ISO 9002 by LRQA. I specialized in the operation/production and technology management, quality control in the food & beverage, chemical/mechanical engineering and pharmaceutical enterprises.

Branch head of operation management