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：

 Establish and maintain appropriate documentation as required for quality assurance and quality system.

 Maintain and improve incoming, in-process quality control, finished goods release procedure, provide technical support of process validation and risk management control.

 Responsible for inspection instrument qualification and test method validation.

 Provide quality support for new product design and development.

 Perform investigation of NC, CAPA, complaint as need.

 Review inspection reports and NCR, product disposition.

 Assist in training of production and inspectors on quality knowledge.

 Participate in process/quality improvement projects.

Requirements：

 Bachelor's degree or above in mechanical/medical device/optics.

 3-5 years related work experience or demonstrated performance.

 Good communication skill and teamwork spirit.

 MD GMP/ISO 13485 knowledge preferred.

 Fluent in oral English is preferred.