Tuesday, May 18, 2010


1. Maintaining current management ralph lauren polo shirtssystem as well as establishing and implementing new management system if necessary.ralph lauren polo shirts
2. Integrate different management systems such as ISO9001, 14001, 13485, QC080000 and GMP into the optimized one. north face jacketsnorth face jackets
3. Leading for internal audit and preparing for management review reports periodically.4. Coordinating customer audit/survey and follow up customer CAR.5. Preparing for third party audit and escorting UL field representative to conduct on-site inspection.
6. Acting as a leader for new supplier qualification audit, setting up action plan for improvement and following up supplier’s corrective actions. nike running shoesnike running shoes
7. Ensuring that all incoming materials and F/Gs are compliance with customers’ hazardous substance control requirements and EU RoHS requirements. 8. Assisting Facility Department to complete equipment qualification and Engineering Department to develop process validation protocol, establish technical file, validation master plan, etc.9. Leading for NWQS (Nypro Worldwide Quality System) implementation.
10. Conducting QC 080000, GMP/FDA, NWQS training for relevant people.Achievements:Coordinate with Nypro China Quality Director and Corporate Quality Director for establishing Environmental Management System (ISO 14001), cGMP’s (Current Good Manufacturing Practices) and Nypro Worldwide Quality System (NWQS) for Nypro Shenzhen. Leading to establish Quality Management System for Medical Devices (ISO 13485: 2003) and Hazardous Substance Process Management System (QC 080000) for Nypro Shenzhen successfully. Detailed achievements as below:
. Sept, 2006--- Pass Microsoft QSA, CSR, and RSC audit2. April, 2006 --- Pass IECQ QC 080000: 2005 certification audit and make Nypro (Shenzhen) be the 7th company worldwide to receive the QC 080000 ? IEC: 2005 certificate and also the 1st in IT industry to receive this certificate. 3. March 2006---Pass ISO 14001: 2004 conversion audit4. Feb, 2006---Pass ISO 13485: 2003 certification audit
5. Jan, 2004---Pass ISO 14001: 1996 certification audit 1. Establishment, implementation and maintenance of QMS (ISO9001: 2000) and EMS (ISO14001: 1996)2. Periodic internal audit and management review3. Customer survey/audit and C/A follow up4. Sub-contractor audit and assessment5. Document 6. Equipment calibration7. UL spot-check8. Third party audit and C/A follow up 6. Phase in and implement NWQS successfully for Nypro (Shenzhen)http://www.auslandschweizer.ch