Quality Manager 质量经理 (职位编号：002)招聘_罗宾逊医用器械（合肥）有限公司最新招聘信息-猎才医药网

Quality Manager 质量经理 (职位编号：002) 合肥

罗宾逊医用器械（合肥）有限公司

月薪： 1-1.5万/月

5-7年经验
本科
招1人
11-09 发布

五险一金
餐饮补贴
绩效奖金

职位描述

职位描述： 1. 请参考英文版的工作说明。2. 温馨提示：请提交英文简历。3. 一级面试会是双语（中英双语），二级面试会通过长途电话（英国）全英语面试。Purpose of job:1. To champion, provide and maintain Quality Management service and system in compliance to ISO13485 and FDA 21CFR 820.Responsibility:1.To create, implement, certify and maintain Quality Management system conformance to Medical Device directive / regulation (ISO13485, FDA 21CFR 820)2. To ensure all key suppliers are validated before commencement of supply, and audited on a regular basis to safeguard high standards and ethical trading.3. To be the ethical champion of the business ensuring all parts of the business play their role in compliance and raising awareness. To maintain the following ethical system SMETA and LSAS.4. To conduct advanced planning such as FMEA, Quality Plan, Supplier First Off sample, HACCP's.5. To liaise with the UK RHC regulatory affairs team providing necessary information for the upkeeping of Company Technical Files and optimise company performance.6. As Management Representative for external audits.7. To coordinate product and process development trials, maintaining specifications of raw materials, semi-finished goods for inhouse production to ensure that quality and regulatory requirements are met.8. To manage, supervise and develop Quality Control Technicians. 职能类别：医疗器械生产/质量管理关键字：质量经理管控经理质量管理