Design Quality Engineer 上海

月薪： 6-8千/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： 职责描述：Be the core team of design control process and ensure product design quality.Design Control of quality function:-Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.-Leader to ensure robust verification & validation, and transfer of product designs are established.-Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems.-Review technical document and product specification.Verification and Validation:-Expert in verification and validation procedures and approaches for robust qualification of product and process designs.-Provide quality approvals of plans, procedures, and reports for verification and validation activities and ensure robust justification of all protocol deviations and non-conformances.Regulatory:-Provide guidance on compliance requirements for ISO, MDD, QSR & SFDA regulations.-Partner with regulatory experts for initial regulatory review in support of design change request.-Support CE and or FDA technical documents submitting.Quality Engineering:-Provide expert statistical support for DOE (Design of Experiments), sampling plans capability assessments hypothesis tests.-Provide reliability/stability objectives & assessment plans.-Support risk assessment activities: FMEA, FTA.Project Quality:-Act as QA window and communicate with customer quality for product technical discussion.-Facilitate new products/customer launches form quality control point of view.任职要求：Bachelor or above in engineering or scientific disciplineBilingual: English/Mandarin requiredQuality assertiveness and quality mindedness.Project management – support multiple projects simultaneously.Organizational – can synthesize information from a variety of sources＞3 years as Design quality 职能类别： 体系工程师 医疗器械生产/质量管理 关键字： 设计质量

联系方式

上海市浦东新区世纪大道1777号东方希望大厦11楼E座

公司信息

Sol-Millennium是一家专注于一次性医疗器械研发，制造与市场销售的跨国公司。公司总部位于上海浦东，并在美国亚特兰大，波兰华沙以及巴西圣保罗设有分公司，分别负责亚太，北美，南美以及欧洲的市场拓展，销售与客户服务。Sol-Millennium目前在全球已拥有100多项相关产品的专利技术，为近50个国家的护士与病患提供我们的优质的产品与服务。 Sol-Millennium致力于为我们的客户提供高品质，与众不同的设计的产品，以及本地化的临床销售与便捷物流服务，同时我们也致力于与我们的客户一道，通过持续研发改进，为我们的客户提供更多优质的产品，以进一步满足客户的需求。

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