Job title：QA engineer

Responsibilities：

1. Responsible for the management of product quality throughout the life cycle of the product;
2. Responsible for product validation at the stage of product design development and change to guarantee product qualit;
3. Development and tracking of product design validation plan;
4. Responsible for establishing pre-and post marketing regulatory plans for the products;
5. Solve the major quality problems in the production process after the product mass production
6. Collecting, recording, handling customer complaints;
7. Report suspected adverse events to regulatory authorities as required and follow and close corresponding adverse event reports as required;
8. Organize a product quality review meeting to review the product quality report;
9. Regularly report the quality data after the product has been marketed, such as complaints, recalls, etc. guarantee the accuracy and integrity of the data;
10. Complete the other work arranged by the leader.

Eligibility：

Education/Major：	Bachelor degree or above
Age：	20-40
Experience：	At least 3 years experience in design verification or testing, or at least 3 years experience in production and post-marketing quality management, (Life cycle product quality management experience is preferred, working experience in the aseptic medical de
Knowledge：	Mechanical, material, chemical, biological and other engineering or science
Technical Ability：	1. familiar with ISO13485 quality management system standards and relevant laws and regulations of medical devices  2. familiar with MS Office, familiar with quality statistical analysis tools, have basic english listening, speaking, reading and writing ability
Credentials：	Certificate of Registered Quality Engineer, Six Sigma Black Belt, ISO 13485 Internal Auditor
Qualities：	Strong system thinking ability, good coordination and problem solving ability.