深圳招聘

职位描述：
This position is primarily responsible for assuring the Quality Systems compliance to ISO13485, relevant regulations and standards; and assists in creating and maintaining the necessary documents and records needed to support these efforts by performing the following duties.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1.Core duties and responsibilities include the following. Other duties may be assigned.
2.Creates and maintains a quality ISO13485 system audit schedule and audit plans.
3.Conducts ISO13485 system, product and process audits and reports on findings.
4.Coordinates customer related complaints/returns and facilitate analysis and customer feedback.
5.Monitors customer complaints; alerts staff to quality concerns; issues return material authorizations, nonconforming material reports, and corrective actions.
6.Manages the collection and correlation of quality data, generate quality metrics and reports on company objectives and key-deliverables.
7.Monitors quality systems, product, process complaints, and corrective actions to assure their expeditious handling and closure.
8.Manages the Inspection Measuring and Test Equipment (IMTE) calibration program.
9.Implements effective employee training on quality system regulations (Food and Drug Administration, Title 21, Part 820), standards (ISO 9001, ISO 13485) related processes, and best practices.
10.Supports quality, product and process initiatives; other activities and responsibilities as required.

    深圳市尼士康科技有限公司是一家医疗设计公司和制造业的合作伙伴，专注于开发智能、技术驱动、卫生和健康解决方案。我们相信以患者为中心的下一代智能医疗设备能够通过强大的协作来克服复杂问题。
    公司创建于2012年，厂房建筑面积约为2600平米，拥有来自各地的研发精英团队，主营业务有设计、开发、生产医疗机械有关的整机和零部件、生产经营机电产品、五金和配件，货物进出口等。主营产品为：气泵、淋巴循环辅助治疗仪、TPU排气软管、直动式电磁阀等小型医疗机械组装产品。产品百分百出口美国，所有客户总部坐落在美国，公司美国总部负责市场的开发和新产品的研发，我公司主要负责在中国境内的供应商开发和产品的生产以满足美国客户订单的要求，所以我司是以出口为主的生产企业，未来也会更加专注和投入国内医疗的研发与生产，近期研发产品为心血管导管和外科手术器械，我们会继续前进扩大企业的发展，成为高科技的医疗产业。

公司地址：深圳市宝安区福海街道怀德翠湖工业区13栋1楼

企业福利：
1. 实行五天八小时工作制，周末双休；
3. 五险一金人性化的社保福利，公积金缴交比例为8%;
4. 各种节日发放精美礼品；
5. 娱乐活动：年度旅游活动、聚餐、BBQ、年会抽奖、KTV等丰富的业余生活；
6. 开心、快乐的工作环境：惬意轻松的工作氛围和充满活力的团队文化；