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.