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Lead Quality Engineer - IVD Instrument
1.5-2万·13薪
人 · 本科 · 5-7年工作经验 · 性别不限2024/11/22发布

苏州工业园区苏虹西路35号

公司信息
罗氏诊断产品(苏州)有限公司

外资(欧美)/150-500人

该公司所有职位
职位描述
罗氏促进多元化、公平性和包容性,代表我们所服务的社区。在全球范围内处理医疗保健问题时,多元化是成功的关键因素。我们认为,包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性,共同抱持对卓越护理的热情。加入罗氏,每个声音都会得到重视。
职位
The What
* Perform activities as required to meet Q&R goals and objectives
independently and leads through the performance of these activities. Able to
identify improvements and implement with collaboration from supervisor.
Participate in cross functional Global initiatives. Acts as a coach for
colleagues with less experience and helps them develop skills/expertise.
* Participate in audits.
* Document draft or revision as required to support changes.
* Able to troubleshoot issues as they arise, implement cost effective and
non-complex actions solutions to ensure that daily work is completed without
jeopardizing compliance.
* Ability to work day to day without supervision to correctly complete daily
scheduled and unscheduled activities. Initiates activities independently and
initiates interactions across departments as applicable.
Main Tasks & Responsibilities
1. Product Release
* Perform Product Release tasks following defined business process.
* Provide product release related KPI trending in timely manner.
2. Product Partnering and IRM Management
* Be responsible for IRM implementation within RDSZ and ensure variance, OOS,
NC and CAPA is carried out in accordance with IRM GSP within RDSZ.
* Involve in any product problem meetings in accordance with the
specifications. In the event of product problems /complaints – the respective
NCs/CAPAs (corrective and preventive actions) are defined as well as being
processed with the appropriate priority and implemented in due time, including
a criticality assessment and possible escalation to the Safety Board if
applicable.
* Support IRM in PIU QM Module for variance, reprocess and rework, NC, CAPA,
QN/SN implementation.
3. Change Management
* Drive change lead and subject matter experts in RDSZ and dual site
implement local change and dual site change in a compliance manner.
* Provide change related KPI trending in timely manner.
4. Provide QA oversight for RDSZ outbound products’ logistics claim
* Ensure the outbound logistics claims are handled following GSP.
5. Other tasks assigned by line manager
我们是谁
在罗氏,来自100个国家的100,000名员工不断推动着健康医疗行业的进步。我们一同工作,使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化,也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域,罗氏设定了远大的计划,坚持学习和发展,并不断寻找与之志同道合的伙伴。
罗氏提供平等的职业发展机会。

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