Qualification:
1. Engineering or Quality background, college degree or above.
2. At least 5 years' quality engineering experiences in injection moulding& sub-assembly.
Familiar with medical industry will be a plus.
3. Good knowledge in ISO9001/TS16949/ISO13485 and cGMP.
4. Good communication and problem-solving skills.
5. Fluent in both oral and written English is necessary.
6. Familiar with multiple quality tools, ie. SPC, 8D, Minitab, DOE, etc
7. Rich experiences in medical industry Process validation FAT/SAT/IQ/OQ/PQ etc.

Job Description:
1. Maintain and improve the current quality management system.
2. Initiation of WI, Quality inspection plan, Control plans and PFMEA etc.
3. Weekly quality reporting on all aspects of whole Dept’s performances.
4. Drive internal weekly quality meeting for continuous improvement and take the role to evaluate the effectiveness of action plans.
4. Implementation of ECNs.
5. Provide necessary Quality training within the facility.
6. On-time trouble shooting for product quality issue, and deal with nonconformity products in process.
7. Handle Customer feedback, alert and complaints
8. Maintain the DCC system.
9. Participant in NPI team and support with metrology review and professional process validations.
10. Supportive to manage IPQC and OQC inspectors team
11. Supportive to manage supplier quality
12. Fulfill other responsibilities as assigned by the management.