职位介绍

工作职责：
- Establish, implement and improve company quality management systems such as ISO9001/ISO13485/QC080000/BRC CP / FDA QSR.
- Arrange and join in system process planning and optimization. Initiate, revise and issue system documents such as Quality Manual, SOP and respective WI, and give training to all departments.
- Drive and facilitate the function departments to implement customer QMS policy/procedure‘s requirements.
- Communicate with customer and third party for any customer audit or 3rd party external audit.
- Monitor and maintain the QMS KPI, and review the KPI effectiveness with cross function team.
- Conduct process audits and factory internal audit against various aspects of ISO standards and customer requirements.
- Work closely with various departments to create the CAPA (corrective and preventive action plan), and facilitate the follow up of CAPA.
入职要求：
and decision making capability
- Solid knowledge and experience in coordinating with internal parties to create the corrective and preventive action plan, and follow up it accordingly.
- Solid knowledge and experience in handling of customer audit, and 3rd party audit.
- Solid knowledge and experience in establishment and implementation QMS such as ISO9001, ISO13485, QC080000, BRC CP, FDA QSR, GMP, QAKE, etc.
- Familiar with 7 Quality tools, Why-Why analysis, 8D approach,
5907 0364-|171 5290 8215 27- Formal training in quality management system or ISO9001 lead auditor is an advantage.