Sr. Quality Engineer
Main Tasks / ????
- 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 / ????
- Bachelor or above with major in Medical equipment, Machanical, Electronics, Biology, Chemistry, Medicine, Pharmacy, Chemical industry, Computer Science
Experience / ??
- 3- 5 years of experience in QMS
Other skills / ????
- Being fluent in English written and verbally, good documentation, communication skills are essential
- Experience with a quality management system (QMS) for ISO9001, ISO 13485 and GSP are highly desired
- Internal Auditor of ISO 9001
- Experience of document control system is a plus
À propos de l'entreprise