质量工程师

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质量工程师 5-9.9千/月/月

微仙医疗科技（杭州）有限公司

杭州

本科
03-01 发布

职位信息

职位名称：质量工程师

类别名称：

职位描述：

职位描述：1.Prepare quality specifications and receiving specifications起草制定产品检验规范（包括来料和成品）2.Coordinates and assists with first article inspections负责安排首件确认3.Coordinates and supports product testing (e.g. biocompatibility testing)配合支持其他产品相关测试（如：生物相容性检测）4.Conducts test method validations负责检测方法确认、验证。5.Works with manufacturing engineers to review product /process changes and resolve product quality issues.与生产工程师合作, 完成产品或工艺过程变更的评审执行，处理日常发生的产品的质量问题。6.Works with suppliers to maintain high quality levels of incoming production materials. 及时与供应商沟通来料的质量问题，确保问题得到及时解决。7.Conducts quality audits of suppliers. 负责供应商审审核和评估。8.Coordinates implementation of new equipment used for inspection by preparing equipment specifications and by participating in installation qualifications and operational qualifications 负责检验设备的标准制定，安装和运行确认，以及员工使用培训。9.Supports the manufacturing of new products 配合新产品转移。10.Develop test protocols and reports (design verification, design validation, process qualification and process validation) 针对设计确认、过程确认等，负责编写制定确认方案和执行。11.Develop the PFMEA. 负责制定维护PFMEA12.Supports various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing and quality metrics data analysis 针对质量报告（如CAPA，NCR，供应商质量报告，设备校准报告，内审等等）进行数据分析。13.Perform training & certification to QC on Inspection.负责QC检验方面的培训和考核。14.Conduct Sterilization process validation (including EtO & E-beam sterilization). 负责执行灭菌过程确认（包括环氧乙烷灭菌和电子束灭菌）15.Review the DHR. 对产品历史记录进行评审。16.Duties as assigned 完成上级安排的其他工作。

任职要求：

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