JOB SUMMARY 工作汇总 Enhance the capabilities of the Quality Assurance Department by providing technical and administrative support to the engineering group in improving quality and yield of the products.
JOB DESCRIPTION 职位描述 1. Yield Analysis and Process Support - Monitor process yields throughout the line. Recognize and help solve yield-decreasing problem, and implement and drive internal corrective actions. 2. Experimentation - Carry out experimentation, process capability studies, or other technical evaluation to improve yield and quality. 3. Customer Corrective Action Support - Drive customer corrective actions by carrying out root cause failure analysis, cross-sectioning, dimensional analysis, or other means. In addition, communicate with customers when necessary to ensure verification of corrective actions. 4. Internal Communication - Ensure production information is communicated consistently and effectively throughout the line and from shift to shift. This communication might include inspection instructions, customer complaints, production scheduling, or other specific instructions. 5. MRB and Purge - Participate in purge and MRB meeting to ensure proper disposition of discrepant material. 6. Visual Aids - Ensuring that proper visual aids for inspection and for SPC data keying are available for Manufacturing and Quality Assurance Department. 7. Deviation Authorization - Ensure the process being done is in compliance with the Deviation Authorization. Follow up on the changes of the effective and expiry date. 8. ECN - Participate with the team members on its implementation and follow up on the stimated effective date and commitment from workcell members. 9. Have the responsibility of choosing non-toxic or low- toxic material, low noise and energy saving and safe production machines. 10. Repair & maintain and check safety protective equipment; and ensure it in good condition. 11. Must consider environmental & safety & health issues when initiating a new project or new product or new production line. 12. Wear right PPE and operate safety, attend occupational disease medical examination, fire drill and EHS training. 13. Identify and sort waste in a way. 14. Must follow RBA provision.
GENERAL REQUIREMENTS 基本要求 1. Bachelor Degree/Diploma in Electrical/Electronics engineering is perforable or at least 3 years experience in the Quality related or engineering field. 2. Proficient and knowledgeable in all areas related to the Quality Assurance function. Able to communicate clearly and effectively in both verbal and written media. Able to lead and coach all Quality Assurance personnel to enable them to be more independent and take ownership of their efforts. 3. Familiar with the ISO 9001 / ISO13485 / MedAccred etc. quality management systems requirements, as well as US FDA / MDSAP/ China Medical Device Manufacturing Quality Management Regulation (China FDA Notification No. 64 of 2014) and related appendix, and corresponding regulations, and is able to build up quality awareness and quality improvements.
