苏州招聘

职位描述：

*Main Responsibilities:

This position is mainly focus on techncial file administrate, do not repeat the CV.

1.Ensure the product technical file/design history files meet the regulation requirement.

2.Provide technical support for saving, quality or any other improvement

3.Maintain the technical files/Design history files for the product

4.Work together with UL and group RA team to keep the files are up-to-date

5.Be responsible to maintain the risk management files of the product

6.Be responsible for engineering changes

7.Be responsible for the Technical files/Design history files transfer from R&D or other sites

8. Be responsible for techncial audit from notified body or FDA

*Work Experience:

1.5+ year’s work experience with techncial or similar roles at medical device international company

2.Be familiar with Technical files/design history file structure and requirement

3.Be familiar with the regulatory requirement for the medical device, like MDD, FDA, CFDA, etc

4.Be familiar with the ISO 14971 and ISO 13485, and design control procedures

5.Familiar with standard like, IEC 60601-1 and relevant standards

6.Have Experience to work with UL, TUV or any other 3 party testing company is preferred

7.Be good at MS Word, Excel, and PowerPoint.

*Education & Certifications:

Bachelor degree or above, for Mechanical or electronics, electronics is preffered.

Female is preffered

*Languages:

Good English communication skills.

*Personal Characteristics:

1.Self-motivated, Proactive, team working and positive thinking.

2.Good communication and coordination skills.

3.Good problem solving skill

4.Can work under high pressure.

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洁定集团是总部位于瑞典的上市集团公司，洁定感染控制业务(GETINGE)是其三大业务领域之一。洁定感染控制业务由卫生保健和生命科学两部分组成。加上延伸护理业务（ARJO HUNTLEIGH）和医疗器械业务（MAQUET），洁定集团公司关注最先进的医疗技术。截至2009年底，洁定集团销售总额达到230亿瑞典克郎,共有约12100名员工，其中中国大陆大约有400名员工。
在全球卫生保健和生命科学领域内，洁定感染控制业务处于消毒器和灭菌器供应商的领先地位。自100多年前成立至今，洁定感染控制业务制作成为了消毒灭菌领域改革创新和科技进步的象征。洁定感染控制业务分为三大客户部门。
- 卫生保健
- 药物/医疗器械
- 调研
Getinge Infection Control (GETINGE) is one of the three business areas within GETINGE AB, a publicly-listed, Swedish-based group of companies. The Getinge Infection Control business area consists of two divisions: Healthcare and Life Sciences. Together with the two other business areas, Extended Care (ARJOHUNTLEIGH) and Medical Systems (MAQUET), the entire GETINGE group of companies focuses on state-of-the-art medical technology. For the fiscal year 2009, the GETINGE Group posted sales revenues of 23 billion SEK with a workforce of approximately 12,100 employees with 400 of these employees in Mainland China.
Worldwide, Getinge Infection Control ranks among the leading providers of disinfectors and sterilizers within the healthcare and life sciences segments. Since its foundation more than 100 years ago, Getinge Infection Control has stood for innovation and technological progress in the field of disinfection and sterilization. Getinge Infection Control has three customer segments:
- Healthcare
- Pharmaceutical/Medical device
- Research
   
洁定集团-延伸护理事业部：
Extended Care Business Area
涵盖的业务
Business activities
为卫生基础护理、老年人/残疾人护理提供系统产品服务，以减低他们行动的困扰和痛苦。
Systems for hygiene routines and the transfer of the elderly and disabled, as well as products that prevent and treat pressure sores.
所涵盖的产品范围有：沐浴/冲淋产品，病人手扶支架设备和临床实验用褥垫。
The product range covers bath and shower products, support equipment for patient handling, and clinically-tested mattresses.
战略/Strategy
产品领先：通过产品改进不断开拓和拓宽市场。
PRODUCT LEADERSHIP. To continuously develop and expand the market through product development.
综合的解决方案：在该业务领域中用审慎的眼光，宽广的产品涵盖范围和完善的销售组织，能够对我们所处的业务环境、服务的质量提供最大程度上的保证。
INTEGRATED SOLUTIONS. The business area’s board product range and well-developed market organization with a consultative focus, will enable a wider range of responsibility to be taken for the working environment and quality of care.
有益的客户记录系统：记录/归档从护理人员和接受护理者得到的反馈，是洁定向客户和投资人提供的最积极的解决方案。
DOCUMENTED CUSTOMER BENEFITS. The documented positive effects for caregivers and care recipients will be the basis for Getinge’s offering to customers and enable new financing and payment solutions.
洁定的价值观/Value
“公开、可靠、自尊、自信”——公司秉持的价值观，使洁定在众多竞争对手中彰显特色。
Openness, sustainability, pride and confidence are the values that will characterize Getinge’s business.