东莞招聘

Reports to:
Hong Kong General Manager with oversight from U.S. Executive Director of Regulatory and Clinical Affairs

Job Description:
The Manger of Quality is the appointed Management Representative for its ISO14385 and FDA Quality Systems Regulations program. This position will have overall responsibility for assuring that system requirements are effectively established, implemented and maintained in compliance with CGMP’s and other regulatory requirements. In this role you will –

RESPONSIBILITIES:
1.Overall responsibility for assuring that both HongKong and DongGuan sites comply with all related aspects of regulatory agency compliance.
2.Obtain and maintain certification to ISO 13485, China SFDA and FDA site registration.
3.Direct quality personnel in the establishment, training, implementation and monitoring of quality procedures.
4.Facilitate all external customer matters relating to quality system.
5.Develop Quality System procedures to enhance overall Quality performance and compliance.
6.Assure that all sites are trained and understand all current regulatory requirements.
7.Host all medical device related site audits. Document audit results and communicate to management responsible for the sites audited all finding, observations and any resulting Corrective Actions.
8.Conduct internal quality audits at regular intervals to assure that the Quality System is in compliance with the established Quality System requirements to determine the effectiveness of the Quality System and report to executive management on their effectiveness.
9.Review all external audit requirements, results pre and post.
10.Report to executive management at defined intervals on Quality System performance to ensure its continuing suitability and effectiveness.
11.Will participate in the coordination, review, investigation and documenting of complaints relating to possible medical device reporting as required by the applicable, FDA, ISO and EN quality system requirements.
12.Chair Quality System Management meetings which gather and report on the on Product Quality and related System.
13.Participate in the correction, prevention and documenting customer complaints investigations which may be relating to possible medical device reporting as required.
14.Assure that all sites are trained and understand all current Quality System requirements.

QUALIFICATIONS:
1. BS or BA in a biomedical science, engineering or medical technology.
2.10+ years experience in quality assurance for medical devices.
3. Proven leadership skills.
4. Supervisory and management experience. Strong communication skill.
5. Proficiency in written and spoken English. Cantonese and Mandarin are desirable, but not required.
6. Ability to travel, internationally

厂房面积超过8千平方公尺, 并拥有行业全套先进生产设备, 主要生产设备均由美国进口。

公司福利：
1、公司免费提供早餐、午餐、晚餐（午、晚餐为三菜一汤）。
2、公司为夜班员工提供相应的夜班补贴。
3、公司免费提供住宿，水电费全免。
4、职员每周五天8小时制。
5、工资发放准时，全员社保。