• 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 做五休二
  • 带薪年假
  • 五险一金
  • 免费班车
  • 绩效奖金
  • 节日福利
  • 专业培训
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴

职位描述

职位描述: Title: Quality System EngineerReport to: Quality ManagerJob Summary:1.Quality planning, validation and control for projects and in-sourcing projects 本地研发项目和转移项目的质量策划,过程验证和质量控制等2.Establish clean room quality management control system, be familiar with clean room aseptic environment test, such as dust particle number detection, floating bacteria, sedimentation bacteria, air volume, wind speed, illuminance, etc.;建立洁净室质量控制系统,熟悉洁净室无菌环境检测,如尘埃粒子数检测、浮游菌、沉降菌、风量、风速、照度等3.Rich experience for the GMP production workshop and be familiar with the sterile product quality control. FDA audit experience is preferred具备无菌GMP生产车间以及无菌产品质量管控QA经验,有FDA审核经验优先.Responsibilities/岗位职责:1.Setup the Cleanroom quality control system,include the cleanroom environment control and product cleanness. Participate in the company quality management system self-check and GMP,FDA certification洁净室控制系统的建立, 包括环境控制和产品控制要求. 参与公司体系自检及GMP、FDA认证等工作2.Coordinate with project team for the documentation, deviation and risk assessment as well as the process engineering change from both internal and external与项目团队一起参与文件编制、偏差、风险评估管理,参与项目团队内部或外部的工程变更3.Review the product Specification, drawing and special requirement for new project新项目产品规范,图纸和其他要求的评审4.Work with team of the NPI and setup the quality control plan for the new product. Summarize the validation report together with the project team members与项目团队一起进行新产品导入,对新产品建立质量控制计划,完成验证计划5.Work out the related document for Medical project, as DMR, DHR, FMEA, etc.医疗项目的其他文件起草,如DMR,DHR,FMEA等6.Design quality plan, inspection instruction, and test method for new project定义新项目的检验计划,检验指导书和测试方法7.Training for inspector for quality plan, inspection instruction and test method. 对检验员进行检验计划,检验指导书和测试方法的培训8.Customer complaint responding, corrective action follows up.处理客户投诉及纠正措施的追踪9.Response for stopping the line as any serious issue in process and nonconformity products controlling.过程中出现任何质量负责中断生产和不合格品的控制10.Cooperate with RA team for the product registration for domestic project协助法务部门完成国内销售的产品注册11.Collect process quality data and quality trend analysis.收集过程质量数据并完成趋势分析和改进12.Fulfill the other tasks assigned by the manager. 上级安排的其他任务Requirements/岗位要求:1.Bachelor degree or above with Good English skill both in written and oral.本科或以上学历,良好的英语读写能力2.At least 5 years relevant working experience in international company, any medical device manufacturing experience is preferred.5年以上的外企相关工作经验,有医疗生产企业工作经验优先3.Be familiar with process management and new project quality management.熟悉过程管理和新项目的质量管理4.Be familiar with ISO13485,GMP and FDA regulatory requirement熟悉ISO13485以及GMP.FDA法规要求5.Good communication and team work skill. 良好的沟通能力和团队合作能力6.With responsible, careful personality and work under high pressure 细心,责任心强, 能胜任高压工作 职能类别: 体系工程师 医疗器械生产/质量管理

联系方式

工业园区

公司信息

汇杰是一家专业国际招聘咨询服务公司,致力于为企业提供中高级专业人才的招聘解决方案。汇杰咨询在2004年创办于苏州,现在已经成长为中国长三角地区最专业的人才服务机构之一。 汇杰扎根于中高端人才的招募,专注于工业制造、能源化工、医药医疗、消费品、教育、现代服务业、通用职位等行业的招聘。 我们的招聘领域包含:高层管理、工程与运营、人力资源、信息技术、市场营销、供应链、财务等领域。每个岗位职能又可以按照行业细分到更深层次的不同职能。

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