Main responsibilities & duties Start-up phase: Take part in process validation. Build up testing capacity regarding products, including setting up inspection procedures, material/product specifications and qualify testing equipment. Operate inspection procedures
Routine production: Perform batch record review to develop quality metric and drive defect reduction effort. Perform statistical analysis of process data; interpret, compile and organize results. Address product quality issues and organize quality improvement Cooperate with other QEs for complaint investigation Authorize to release material, in-process product & FG(If they meet the pre-defined spec) relating to his/her responsible product line.
1. Education required/ preferred - A bachelors degree in scientific or engineering discipline. - Mechanical or Electrical education background as a plus 2. Work experience -Minimum 2 years experience in quality field in manufacturing environment. -Experience in medical device and/or knowledge of a wide range of manufacturing technologies is desired. - Experience in sterile device manufacturing as a plus 3. Competency/ Skills - Understand requirements of process/equipment validation 4. Qualification/ Credential - 6 sigma certificate as a plus 5. Language/ Computer - Fluent verbal and written English - Good computer skill of Microsoft application software 8. Others - Good communication skill and team spirit