长沙招聘

职位描述：
Validation Engineer 验证工程师，工作地点：苏州，苏州有班车提供
欧美医疗器械总部职位
负责公司新产线的验证工作
要求：
1.英语作为工作语言，该职位需要和德国总部保持沟通
2. 医疗，医药，营养品行业任职经验
3.熟悉ISO13485, GMP等医疗器械相关的法律法规
4.理工科优先

Job Summary and Area of Responsibility职位概述以及职责范围:
？ Be responsible for all validation activity for AE division including CHIP and VS, including below but not limited –
负责蛇牌事业部的所有验证相关事宜,包括手术器械和心血管项目,包括但不限于以下的工作
？ Reporting the Dailies of executed of Q&V to validation officer of all types of validations incl. process systems, cleaning, equipment, sterilization, clean room, computer systems.
向质量经理汇报日常的所有类别的验证，包括工艺系统、洁净、设备、灭菌、洁净室、计算机系统。
？ Support Quality Manager to participate in execution of approved Q&V protocol via independent action, or cooperation with others.
协助质量经理执行验证活动或与其他部门的合作执行批准的验证计划,　
？ This position will be responsible for guiding and coordinating staff from QC, Prod., ENG of specialists for developing, reviewing, and execution of Q&V documentation through VMP, DP, IQ, OQ, PQ, URS to maintain processes and equipment in a validated status.
负责指导和协调质量部、生产部、工程部负责验证工作的员工有关验证文件的创建、复核、以及通过执行VMP, DP, IQ, OQ, PQ, URS保证、维持工艺和设备的有效状态。
？ This position will also provide training to user departments on the development and execution of validation protocols.
向各部门与验证相关的人员提供创建和执行验证的培训。

Major Duties and Performance Standards to be achieved主要职责及绩效标准:
？ Develop and maintaining VMP and ensure it update to the latest status of plant
创建、维护VMP以确保更新工厂的最新状况
？ In Charge of validation & qualification protocol (DQ, IQ, OQ and PQ) and report.
负责验证，确认方案和报告的编写（DQ, IQ, OQ 和 PQ）。
？ Provide training to related departments on the development and execution of validation protocols.
给相关部门提供验证方案的培训。
？ Perform validation & qualification activities to ensure the process/system/equipment meeting it’s predetermined specification and quality characteristics.
执行验证和确认活动以保证工艺/系统/设备满足预先设定的标准和质量属性。
？ Follow up deviation found in validation & qualification to ensure the deviation is closed properly and on time.
对验证和确认中发现的偏差进行跟踪以保证偏差是正确及准时的关闭。
？ Look into the latest validation requirement and make gap analysis refer to the current status.
观察最新验证需求和根据现行状态分析差异。
？ Other tasks assigned by quality manager.
质量经理安排的其他工作事宜。


Education Required教育背景要求:
？ Bachelor degree or above
本科以上学历
？ Mechanical engineering, medical devices and other validation related major is preferred.
机电工程类,医疗器械等验证相关专业优先.

Experience/Knowledge Required经验及知识要求:
？ more than 2 years experience of quality management for medical device related industry
2年以上医疗行业质量相关工作经验优先
？ 2 year of validation experience
2年以上验证相关经验
？ ISO13485, GMP and related medical device regulation knowledge
熟悉ISO13485, GMP等医疗器械相关的法律法规

Special Skills/Abilities Required特殊技能及能力要求:
？ Good English reading, writing and speaking
良好的英语听、说、读、写能力
？ PC skill including Microsoft
良好的计算机能力 举报 分享

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