>>查看公司介绍 RC Specialist...

工作地点: 常州市 招聘人数: 1人 工作性质: 全职
工作经验: 1年以上 学历要求: 大专 年龄要求: 不限
性别要求: 不限 薪资待遇: 6000-9000 更新日期: 2020-08-15

岗位职责:

    主要工作职责(7 ±2条) Principle Duties and Responsibilities (7 ±2 items)
    Be responsible for establishing and revising relative system documents;
    负责相关体系文件的编制或更改;
    Be responsible for the standardization, distribution, withdrawing, obsoleting and archiving of non-technical system documents, including specified responsibilities of Document Controller in documents;
    负责非工艺类体系文件的标准化、发放、回收、作废、归档,包括文件规定的文控员职责;
    Be responsible for following up and maintaining results of quality objective;
    负责质量目标的跟踪和保存结果;
    Be responsible for verifying revisions of standards and regulations related with quality management system establishment by visiting relative websites;
    负责访问相关网站来验证用于建立质量管理体系的标准或法规是否现行有效;
    Be responsible for regulatory training;
    负责法规知识培训;
    Be responsible for reviewing process validations, software validations, quality plans and Change Control.
    负责复核过程确认、软件确认,质量计划和变更控制;
    Be responsible for scheduling and following up internal audits and external audits;
    负责安排及跟踪内部审核和外部审核;
    Be responsible for following up the progress of converting corporate procedures into ZBiomet QMS;
    负责集团文件的转化进度的跟踪;
    Be responsible for products notarization and legalization;
    负责产品的公证和合法化;
    Be responsible for coordinating CAPA process and follow up with CAPA progress;
    负责协调CAPA过程并追踪CAPA进度;
    To finish temporary duty assigned by RC manager.
    负责完成法规经理指派的临时工作。

职位要求:

    experience, knowledge, skills and credentials)
    Bachelor degree or above, major in science and engineering, more than one year’s working experience of quality management system is preferred;
    本科以上学历,理工科专业毕业,有1年以上的质量体系管理经验优先;
    Be familiar with ISO 9001 or ISO 13485 quality management system is preferred.
    熟悉ISO9001或ISO13485质量管理体系优先;
    To be professional and have good professional ethics;
    专业且有良好的职业道德;
    Ability to work more excellently in the task;
    在相关任务的执行中,致力于追求卓越;
    Improve oral English communicative ability and cultural sense continually;
    不断地提升英语口头交流能力和文化意识;
    Learn regulatory policies and rules related to medical device industry.
    学习有关医疗器械行业的法规政策及规章.
    A command of English listening, speaking, reading and writing.
    具备英语听、说、读、写能力。
联系方式
  • 联系电话:
  • 公司地址:上海市长宁区延安西路500号万宝国际广场1901
  • 公司官网:http://zimmerbiomet.com