「南京高淳區(qū) 質(zhì)量體系管理招聘」_2025年維克佳(南京)醫(yī)療器械有限公司招聘-智聯(lián)招聘

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更新于 1月14日

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質(zhì)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(zhì)量管理體系食品安全管理體系FDA認(rèn)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(diǎn)

高淳經(jīng)濟(jì)開發(fā)區(qū)雙高路86-8號(hào)

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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(dú)資企業(yè)，位于南京市高淳區(qū)雙高路86-8號(hào)，注冊(cè)資本為250萬美元。公司主要經(jīng)營生產(chǎn)I類、II類醫(yī)療器械；銷售自產(chǎn)產(chǎn)品；經(jīng)營醫(yī)療器械的進(jìn)料加工業(yè)務(wù)（國家限定公司經(jīng)營和國家禁止進(jìn)出口的商品及技術(shù)除外）；公司自產(chǎn)產(chǎn)品、原輔材料、儀器儀表、機(jī)械設(shè)備、零配件及技術(shù)的進(jìn)出口業(yè)務(wù)（不涉及國營貿(mào)易管理商品，涉及配額、許可證管理商品的，按國家有關(guān)規(guī)定辦理申請(qǐng)）。

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