Main Tasks / 主要任务Be responsible for the maintenance, supervision and improvement of Zeiss quality management system and medical device operation quality management system, including

- Plan and implement internal audit (in accordance with ISO 9001:2015 and medical device distribution regulations), and report the results to Quality Compliance Manager

- Coordinate the third-party audit of Notified Body

- Follow up the implementation and closure of internal and external audit by corrective and preventive measures

Regularly review and update Zeiss quality management system documents to ensure that they meet standards and regulatory requirements

Regular review of quality assurance capability of medical device third-party logistics suppliers and tracking of corrective measures

Implement the initial business audit of medical devices for GSP compliance, including:

-Verification of product registration certificate, Chinese label and IFU

-Approval of dealer qualification

-Approval of customer qualification

Maintenance and improvement of document control system, MD initial business approval system and Chinese identification system.

Carry out training on quality management system and medical device operation quality regulations within the company

Perform other tasks as assigned by supervisor

Education / 教育背景

Bachelor or above with major in Medical equipment, Machanical, Electronics, Biology, Chemistry, Medicine, Pharmacy, Chemical industry, Computer Science

Experience / 经验

3- 5 years of experience in QMS

Other skills / 其他技能

Being fluent in English written and verbally, good documentation, communication skills are essentialExperience with a quality management system (QMS) for ISO9001, ISO 13485 and GSP are highly desiredInternal Auditor of ISO 9001Experience of document control system is a plus