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工作地点: 金华市 招聘人数: 1人 工作性质: 全职
工作经验: 10年以上 学历要求: 本科 年龄要求: 不限
性别要求: 不限 薪资待遇: 面议 更新日期: 2017-11-21

岗位职责:

    Key Position Responsibilities
    ? Direct reports would be the managers within the regulatory compliance department and quality assurance department.
    ? Manage regulatory compliance and quality assurance personnel including expenses/budgets and approves and establishes quarterly objectives.
    ? Performs and provides guidance and/or assist in defining, implementing and follow-up of systematic corrective and preventive actions (CAPA) and approves all CAPAs.
    ? Support domestic and international submissions or other submissions/documentation required by the US FDA, China CFDA and international submission in designated countries.
    ? Provide support for 3rd party audits (FDA, Notified Body) within the SBU.
    ? Functions as Management Representative for Jinhua Plant and lead the organizing, preparation and presenting at management review meetings.
    ? Responsible for the development and implementation of Jinhua QMS procedures, lead QMS Continual Improvement initiatives.
    ? Support Health Hazard Evaluations (HHE) and coordinates on recall notices as necessary.

职位要求:

    医疗器械行业工作经验5年以上,
    担任质量经理/RC经理5年以上
    有推动FDA820符合性的项目经验(包括根据FDA820 & ISO13485搭建、改善公司质量管理体系,并接受FDA或Mock FDA的审核经验
    愿意长期在金华工作,英语流利
    了解机加工工艺者优先考虑
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