苏州招聘

职位描述：
主要职责：
1. 保证CV产品生产和过程控制符合质量体系要求，并完整，有效，确保提供给客户产品保持高的质量水准。
2.根据相关的产品规范和生产工艺，建立和执行产品生产和量产的工艺和质量控制计划。
3.执行完成相关生产过程验证，测试方法验证和日常质量监测活动。
4.根据总部和当地的质量相关要求，建立合适的生产和质量规范，SOP和在线生产工艺和检测工作指导书。
5.培训和认证在线质量检验人员和生产操作人员的所有质量控制活动。
6.参与处理产品异常和内外客户投诉调查。
7. 可适应国内外出差。

主要技能/工作经验：
1. 至少3年以上的制造业的质量工程师经历，有欧美企业质量工程师的工作经验优先。
2. 在医疗行业GMP环境下2年以上工作经验优先。
3. 熟悉ISO9001/13485, GMP和验证操作。
4. 熟悉质量控制的统计学工具，如SPC，MSA，GR&R等。
5. 良好的办公室软件应用水平。
6. 本科毕业、理科专业。
7. 英语说写沟通流利。

个人特质：
1. 良好的系统性思维和逻辑性强。
2. 优秀的团队合作者，沟通者和协调者。

Main Responsibilities
- To ensure CV production and process control is sufficient, effective and compliant with quality system requirement, and provide high quality performance product to customer.
- Setup the process engineering& quality control program from product to serial production lots, according to relevant corporate product/process specification, and incoming inspection.
- Carry out the related process validation, test method validation & routine quality monitoring program.
- Establish quality specification, SOP, and production process engineering& inspection working instruction, with respect to corporate and local quality requirement.
- Train and qualify all quality control activities for all the process operators and process inspectors.
- Handling the related quality nonconformity and internal/external customer complaint investigation.
- The role may require local and international travel.

Required Knowledge/ Skills/Experience
- At least 3 years in quality control experience of manufacturing, if have quality control experience in EU/US company is preferred.
- More than 2 years working experience in GMP environment of medical industry is preferred.
- Familiar with ISO9001/13485, GMP, validation.
- Familiar with quality control statistic tools, SPC, MSA, GR&R etc.
- Good computer and software skills.
- Bachelor’s degree in science or engineering.
- Good English communication both in oral and written.

Personal Qualities
- Great systematic and logical thinking.
- Good team work spirit and coordination skills. 举报 分享

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.