Quality Engineer/产品工程师

职责描述：
1. Quality planning of product, to ensure quality level compliance with design/customer requirement continuously.
产品质量策划，以保证其质量水平持续符合设计/客户的要求。
2. Create and maintain critical components list of product. Create IQC inspection plan of critical components.
创建并维护产品关键元器件清单。创建关键元器件的来料检验计划。
3. Create and maintain test instruction of semi-product and finished product. Train and certified inspectors and operators.
创建并维护半成品，成品检验指导书，培训并认证检验员和作业员。
4. Create and maintain DMR. Support manufacturing engineer for related project documents of medical device, such as FMEA, verification and validation, etc., as well as line trouble shooting and improvement project.
创建并维护DMR，协助制造工程师完成医疗器械相关项目文件，比如FMEA，验证，确认文档等。协助制造工程师的在线不良分析以及改善项目。
5. Participant change control board and implement engineering change order accordingly.
参加工程变更会议，并执行工程变更的要求。
6. Handle internal customer complaint, including necessary corrective and protective actions follow. Provide containment suggestion, regarding to end customer complaint.
处理内部客户投诉，跟踪必要的纠正和预防措施。针对外部客户投诉，提供围堵措施的方案。

任职要求：
1.Must be able to analyse and resolve non-routine product issues using independent judgment and inspection equipment.
具备独立地判断能力，能够使用检测设备分析并解决非常规类产品的相关问题
2.Strong analytical skills, familiar with QC tools. Familiar with statistical tools is preferred.
较强的分析能力，熟练使用质量工具。熟悉统计工具尤佳。
3.Familiar with ISO 13485, & ISO 9001. Internal auditor is preferred. Familiar with FDA QSR820, & CFDA regulation is preferred.
熟悉质量管理体系ISO 13485和ISO 9001. 内审员，熟悉FDA QSR820和CFDA法规尤佳。
4.Oral and written English skills.
良好的口头和书面英语能力
5.Responsible and positive, can work under pressure.
有责任心，乐观的态度，能够在压力下工作。