Job description:
1. Work with plant team to identify and implement opportunities for improvement, cost reductions.
2. Establish and maintain PMF(Product Master File) and relevant quality documents.
3. Fully responsible for complaint handling process and relevant change process towards customer.
4. Support ISO9001 and ISO13485 internal and external audit
5. Support quality manager to prepare, participate customer audit,include ISO9001,ISO13485,QSR820ect. and take corrective actions after the audits.
6. Quality responsible for lead relevant validation process for new project ,such as DQ, IQ,OQ,PQ.
7. Handling of any relevant non-conformance products/materials.
8. Communication with customer regarding all quality tasks, including complaints, changes, COA etc.
9. Relevant supplier evaluation and approval if needed.
Qualification:
1. Bachelor degree or above, major in scientific, engineering or related field required.
2. 3-10 years experience quality engineering in manufacturing field;
3. Strong experience in quality control or analysis of plastic injection;
4. Be familiar with ISO9001, and preferable to have experience with ISO13485, GMP and audit experience.
5. Be experience in problem solving teams with customers.
6. Working knowledge of SPC and SQC,FMEA,applications in a manufacturing environment.
7. Good communication skills, able to employ a structured approach to problem solving
8. Good command of English to directly contact with our customer whose native language is English.
2219 7985-1|171 3616 6621 099. Computer skills – Windows, Office,Minitab
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