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工作地点: 静安区 招聘人数: 1人 工作性质: 全职
工作经验: 8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: 35000-40000 更新日期: 2020-10-31

岗位职责:





    Position: Quality Manger - Value Segment Solutions

    Location: Shanghai

    Your challenge This is a position for an experienced medical device Quality Assurance Manager who, under general supervision, will support the business staff and act as a primary liaison to the business regarding product/process quality and compliance issues.


    Duties and responsibilities include: ?
    Preview, review, and approval of engineering change orders
    ? Review and approval of product/process validation and verification protocols/reports
    ? Review and approval of nonconforming material documentation
    ? Provide process validation leadership
    ? Represent quality on initiative teams (process improvement/implementation) strongly championing business needs
    ? Supports partnership assessment and supplier selection processes as necessary
    ? Interface in manufacturing and design change process including process audits, process verification and validation audits
    ? Quality Engineering process consulting
    ? Responsible to support and be knowledgeable of business specific standards
    ? Influences supply chain processes to improve quality and reliability of products
    ? Supports quality reliability team activities
    ? Independent reviewer for design reviews
    ? Conduct Design History File audits
    ? Participate and review design control activity.
    ? Review product and process control activity.
    ? Maintains current knowledge of applicable national and international regulations, acts as a consultant to other departments.

职位要求:


    ? Perform other duties as assigned by BIU Q&R Director Requirements:
    ? BS in engineering discipline or equivalent education, experience, training.
    ? At least 7 years quality experience in medical device industry
    ? Strong understanding of Quality System regulations (FDA, ISO13485).
    ? Good understanding of statistical methods, quality tools and methodologies (SPC, FMEA, DOE, etc.)
    ? Well-developed organizational and analytical skills
    ? Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects and initiate team building
    ? Communicate globally, across teams and programs, from senior executives to administrative support personnel.
    ? Both detail oriented and able to see big picture
    年薪40-50万
联系方式
  • 公司地址:上海市静安区灵石路718号A1栋