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更新于 4月25日

Source Quality Engineer(外資知名醫(yī)療器械)

1.3-2.5萬
  • 蘇州工業(yè)園區(qū)
  • 5-10年
  • 本科
  • 全職
  • 招1人

職位描述

ISO13485醫(yī)療設(shè)備/器械
? Quality point of contact for Global Supply Chain with select Suppliers and EMs as part of the Supply Base Optimisation Team ? Work at select Preferred Supplier and EM locations to ? Produce advanced quality planning documentation ? Conduct Process Capability Studies, ? Drive cost improvement with the use of PE tools ? Develop and manage First Article Inspections as required at suppliers or within company ? Develop supplier capability in risk assessment such as PFMEA ? Manage training and certification of operators and inspectors to CTQs with the suppliers as required ? Develop and implement efficient and effective inspection points and control plans at the supplier ? Actively support all defined External Manufacturing Quality Systems goals and objectives. ? Conduct on-site quality and process assessments at preferred and EM suppliers both to approve new suppliers and on an on-going basis ? Review, guide and approve Medical Device Validation of new/changed production processes in accordance with company requirements and ISO 13485 as required ? Design and validate Quality System processes where appropriate (CSV and Inspection Process) ? Resolve problems & eliminate constraints to ensure project and supply targets are met. ? Ensure suppliers continue to meet company Quality requirements with regard to PR120-009 compliance ? Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance ? Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc. ? Ensure effective and timely closure on all Supplier Failure Investigation Reports. ? Maintain standards of housekeeping & GMP requirements ? Represent the Source Quality function as required by management. ? Ensure that all Health, Safety and Environmental requirements are fulfilled.

工作地點

蘇州工業(yè)園區(qū)強生醫(yī)療器材公司

入職公司信息

  • 入職公司: 某大型公司
  • 公司地址: 蘇州吳中區(qū)
  • 公司人數(shù): 10000人以上

認證資質(zhì)

  • 人力資源服務(wù)許可認證

    人力資源服務(wù)許可證是由國家人力資源與社會保障相關(guān)部門頒發(fā),代表人才經(jīng)紀人所在企業(yè)可以合法開展人力資源相關(guān)業(yè)務(wù)的資質(zhì)證件。展示該標簽代表該企業(yè)發(fā)布此職位時已上傳《人力資源服務(wù)許可證》或《人力資源服務(wù)備案證書》并經(jīng)由平臺審驗通過。

職位發(fā)布者

胡成民/人事經(jīng)理

剛剛活躍
立即溝通
公司Logo科銳爾人力資源服務(wù)(蘇州)有限公司公司標簽
科銳國際人力資源有限公司成立于1996年,總部位于北京。作為亞洲領(lǐng)先的整體人才解決方案服務(wù)商,科銳國際在中國大陸、香港、印度、新加坡等亞洲地區(qū)擁有超過79家分支機構(gòu),1,500余名專業(yè)招聘顧問,在超過18個行業(yè)及領(lǐng)域為客戶提供中高端獵頭、招聘流程外包、靈活用工、營銷外包、校園招聘、培訓(xùn)、招聘咨詢等解決方案。截至目前,科銳已與2,000余家跨國集團、國內(nèi)上市公司、快速成長性企業(yè)及非盈利組織建立長期合作關(guān)系。其中70%為外資500強企業(yè)。
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