Your Job
Responsible for normal operation of the Quality laboratory, instrument calibration process, inspection of the NPI phase and production phase, including the arrangement of incoming, in-process and outgoing inspection on time.
What You Will Do
1. Responsible for the management of QC leader, Quality technician and inspector, including resource planning, training, coaching, qualification and performance review. |
2. Responsible for daily management of Quality lab to comply with the GLP guildlines, including manpower, equipment/instruments, sample, data and environment. |
3. Rensponsible for the qualification for the test equipment & test method. |
4. Responsible for the calibration and preventive maintenance of measuring or monitoring equipment. |
5. Project Process validation or revalidation execution, including MSA, process capability study etc. |
6. Data analysis to monitor the process stability or continue improve the control process, including inspection data, environmental monitoring data, deviations, CAPAs etc. |
7. Non-conforming material/products handling, MRB meeting organizer; support the CI team to do the continuous improvement. |
8. Management of all non-conformities occur in quality lab and inspection teams. 。 |
9. Other duties as assigned by supervisor. |
Who You Are (Basic Qualifications)
Required: College degree Preferred:Bachelor or above degree. Major in Mechanical Manufacture and Production Engineering Technology.
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Required · Knowledge in GMP and ISO13485. · Good communication skills, fluent English both in written and oral, strong problem solving skills, the knowledge of FMEA/SPC/QC 7 tools. · Good analytic senses · Experienced in measurement. · Knowledge in statistics. Preferred优先:CMM/OGP programing CMM/OGP |
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