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質量體系管理

6千-1.2萬
  • 南京高淳區(qū)
  • 1-3年
  • 大專
  • 全職
  • 招1人

職位描述

醫(yī)療器械質量管理體系食品安全管理體系FDA認證ISO13485
  • Lead the change control process for product changes, process changes, and documentation changes throughout their lifecycle.
  • Evaluate change requests for completeness, accuracy, and compliance with regulatory requirements (e.g., US FDA, CE, ISO).
  • Collaborate with cross-functional teams including Research & Development, Regulatory Affairs, Quality Assurance, Manufacturing, and Supply Chain to assess the impact of proposed changes.
  • Facilitate change review meetings and ensure timely resolution of issues and decisions.
  • Develop and maintain change control procedures, templates, and forms.
  • Ensure that changes are properly documented, including rationale, risk assessment, validation requirements, and verification activities.
  • Provide guidance and training to employees on change control procedures and best practices.
  • Lead and manage multiple projects concurrently throughout their lifecycle from initiation to closure.
  • Develop and execute validation protocols and reports for equipment, processes, and systems used in the manufacture and testing of medical devices including sterilization.
  • Conduct qualification studies for equipment and software, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure that validation activities are conducted in accordance with FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulatory requirements.
  • Develop and maintain validation master plans, protocols, and validation summaries.
  • Analyse validation data, prepare summary reports, and make recommendations for process improvements.

工作地點

高淳經濟開發(fā)區(qū)雙高路86-8號

職位發(fā)布者

尹小英/經理

立即溝通
公司Logo維克佳(南京)醫(yī)療器械有限公司
維克佳（南京）醫(yī)療器械有限公司成立于2014年11月7日，是外商獨資企業(yè)，位于南京市高淳區(qū)雙高路86-8號，注冊資本為250萬美元。公司主要經營生產I類、II類醫(yī)療器械；銷售自產產品；經營醫(yī)療器械的進料加工業(yè)務（國家限定公司經營和國家禁止進出口的商品及技術除外）；公司自產產品、原輔材料、儀器儀表、機械設備、零配件及技術的進出口業(yè)務（不涉及國營貿易管理商品，涉及配額、許可證管理商品的，按國家有關規(guī)定辦理申請）。
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