QA工程师-天津
华外医疗器械（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2012-11-13
- 工作地点：天津
- 招聘人数：2
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语良好
- 职位类别：质量管理/测试工程师(QA/QC工程师) 质量管理/测试主管(QA/QC主管)
职位描述
主要职责：
1、负责公司产品的过程质量控制和新项目及转移产品的质量评审与监控，负责新产品的APQP和PPAP工作，对数据进行整理、统 计、分析。负责质量改进和整改报告的跟踪落实；
2、制定验证计划，并且主持开发阶段的验证活动，确保在量产前所有流程的验证活动全部完成；
3、制定项目质量计划，与整个项目组一起制定项目的质量目标；
4、参与制定项目产品的质量标准和质量控制的要求，将项目产品要求编写成质量检验文件。并负责检验技能的培训和评价设备或仪器的需求识别和配置；
5、进行产品失效的问题分析与改进，不断提高产品合格率，降低产品成本。
岗位要求：
1、大学本科以上学历，机械类专业毕业；
1、负责公司产品的过程质量控制和新项目及转移产品的质量评审与监控，负责新产品的APQP和PPAP工作，对数据进行整理、统 计、分析。负责质量改进和整改报告的跟踪落实；
2、制定验证计划，并且主持开发阶段的验证活动，确保在量产前所有流程的验证活动全部完成；
3、制定项目质量计划，与整个项目组一起制定项目的质量目标；
4、参与制定项目产品的质量标准和质量控制的要求，将项目产品要求编写成质量检验文件。并负责检验技能的培训和评价设备或仪器的需求识别和配置；
5、进行产品失效的问题分析与改进，不断提高产品合格率，降低产品成本。
岗位要求：
1、大学本科以上学历，机械类专业毕业；
2、三年以上相关工作经验；
3、熟练应用QC14大手法等质量控制工具，有质量工程师中级职称者优先；
4、通过质量专业技术资格（中级）考试，并获得证书；
5、熟悉ISO9000质量体系的要求，有ISO9000或ISO13485内审经验者优先。
5、熟悉ISO9000质量体系的要求，有ISO9000或ISO13485内审经验者优先。
6、英语四级以上，读写能力较好；
7、责任心强，工作积极主动，富有团队协作精神。
注：工作地点在泰达开发区。
公司介绍
瑞奇外科成立于2005年, 是美国Reach Surgical, Inc. 在华投资的外商独资企业, 是集研发、生产、销售于一体的专业化的外科医疗器械及医疗设备提供商。
瑞奇外科的产品技术立足高端产品平台, 其全线产品均已获得欧盟CE认证, 且RCS 系列端吻合器已经取得美国FDA的产品认证。目前公司在美国Cincinnati, 北京和上海设有三个研发中心, 致力于为全球的临床外科医生提供先进的和高质量的微创外科解决方案。
瑞奇外科拥有一支专业化的市场销售团队, 恪守“关爱生命、创新不止”的信条， 以高品质的产品服务于全球的临床医生和患者。
公司地址：天津经济技术开发区第四大街5号B座四层（泰达医药研发大厦）——瑞奇外科（总部）
上海浦东新区郭守敬路——华外医疗（上海）
公司网址：http://www.reachsurgical.com/
注：八小时工作制，周末休息
Reach？ Surgical (Beijing), Inc., established in 2005, is a wholly owned foreign enterprise invested by Reach？ Surgical, Inc., a USA medical device company. It is dedicated to providing advanced medical devices and surgical equipments through its global product development centers, manufacturing facility and distribution network in China.
Quality matters as we treasure life. Reach Surgical (Beijing), Inc. follows US c-GMP. All our products have CE approvals and RCS series circular staplers have obtained the FDA approval. Reach Surgical (Beijing), Inc. has three advanced R&D centers in Cincinnati, Ohio, Beijing, and Shanghai. We are dedicated to providing the advanced and best solution of minimally invasive surgery for clinical surgeons.
“Innovating for life” is what we believe in. With a professional marketing and sales teams, Reach Surgical (Beijing), Inc. is devoting to providing our customers products and services of the highest quality.
China Surgical Corporation (Shanghai) is a solely foreign-owned enterprises, a new subsidiary invested by China Surgical (Cayman)Corporation in China.
China Surgical （ Cayman ）Corporation commits itself in developing, manufacturing and selling advanced surgical operational staplers, and it has three serials of products:
1. Open automatic Staplers
2. Endoscopic automatic Staplers
3. Ultrasonic knife operation system
China Surgical Corporation has invested and found Reach Surgical (Beijing) Co., in 2005, thereafter invested and found China Surgical Corporation (Shanghai) in 2007 which is researching, developing and manufacturing micro-port surgical operation instruments.
The core of this company is made up of technical and management experts who have worked many years in American top surgical companies with advanced surgical technology and achievement, and this company cooperate with Peking Union Medical College and Beihang University actively, then build a new road to research, study and develop in the surgical field.
It has class 100000 cleaning room, various manufacturing equipments, perfect machining means and validating means. Its employees are returnees who receive their education abroad and Chinese professional people, and more than 80% of them are bachelors or above.
Guided by the faith “Innovation for life”, this company serves Chinese patients by high-quality products, and provides a serial of advanced solutions for Chinese medical organizations in the micro-port surgical field.
瑞奇外科的产品技术立足高端产品平台, 其全线产品均已获得欧盟CE认证, 且RCS 系列端吻合器已经取得美国FDA的产品认证。目前公司在美国Cincinnati, 北京和上海设有三个研发中心, 致力于为全球的临床外科医生提供先进的和高质量的微创外科解决方案。
瑞奇外科拥有一支专业化的市场销售团队, 恪守“关爱生命、创新不止”的信条， 以高品质的产品服务于全球的临床医生和患者。
公司地址：天津经济技术开发区第四大街5号B座四层（泰达医药研发大厦）——瑞奇外科（总部）
上海浦东新区郭守敬路——华外医疗（上海）
公司网址：http://www.reachsurgical.com/
注：八小时工作制，周末休息
Reach？ Surgical (Beijing), Inc., established in 2005, is a wholly owned foreign enterprise invested by Reach？ Surgical, Inc., a USA medical device company. It is dedicated to providing advanced medical devices and surgical equipments through its global product development centers, manufacturing facility and distribution network in China.
Quality matters as we treasure life. Reach Surgical (Beijing), Inc. follows US c-GMP. All our products have CE approvals and RCS series circular staplers have obtained the FDA approval. Reach Surgical (Beijing), Inc. has three advanced R&D centers in Cincinnati, Ohio, Beijing, and Shanghai. We are dedicated to providing the advanced and best solution of minimally invasive surgery for clinical surgeons.
“Innovating for life” is what we believe in. With a professional marketing and sales teams, Reach Surgical (Beijing), Inc. is devoting to providing our customers products and services of the highest quality.
China Surgical Corporation (Shanghai) is a solely foreign-owned enterprises, a new subsidiary invested by China Surgical (Cayman)Corporation in China.
China Surgical （ Cayman ）Corporation commits itself in developing, manufacturing and selling advanced surgical operational staplers, and it has three serials of products:
1. Open automatic Staplers
2. Endoscopic automatic Staplers
3. Ultrasonic knife operation system
China Surgical Corporation has invested and found Reach Surgical (Beijing) Co., in 2005, thereafter invested and found China Surgical Corporation (Shanghai) in 2007 which is researching, developing and manufacturing micro-port surgical operation instruments.
The core of this company is made up of technical and management experts who have worked many years in American top surgical companies with advanced surgical technology and achievement, and this company cooperate with Peking Union Medical College and Beihang University actively, then build a new road to research, study and develop in the surgical field.
It has class 100000 cleaning room, various manufacturing equipments, perfect machining means and validating means. Its employees are returnees who receive their education abroad and Chinese professional people, and more than 80% of them are bachelors or above.
Guided by the faith “Innovation for life”, this company serves Chinese patients by high-quality products, and provides a serial of advanced solutions for Chinese medical organizations in the micro-port surgical field.
联系方式
- 公司地址：天津经济技术开发区第四大街5号B座四层
- 邮政编码：300457