Job Summary：
Perform various technical duties of quality control and quality assurance such as: Establish quality procedures and test method for raw materials, in-process and finished goods.
Lead the quality control from new product transfer to mass production, manage all validation activities and risks.


Duties & Responsibility：
85 Establish and maintain appropriate documentation as required for quality assurance and quality system.
85 Maintain and improve incoming, in-process quality control, finished goods release procedure, provide technical support of process validation and risk management control.
85 Responsible for inspection instrument qualification and test method validation.
85 Provide quality support for new product design and development.
85 Perform investigation of NC, CAPA, complaint as need.
85 Review inspection reports and NCR, product disposition.
85 Assist in training of production and inspectors on quality knowledge.
85 Participate in process/quality improvement projects.


Requirements：
85 Bachelor's degree or above in mechanical/medical device/optics.
85 3-5 years related work experience or demonstrated performance.
85 Good communication skill and teamwork spirit.
85 MD GMP/ISO 13485 knowledge preferred.
85 Fluent in oral English is preferred.