Quality Engineer 质量工程师
泛太医疗器械(珠海)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:2013-09-04
- 工作地点:珠海
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:大专
- 语言要求:英语熟练
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
Major Responsibilities:
1.Get involved in the new project quality control from sample stage, communicate with project manager &customer for collecting the overall quality requirements, CTQ and production process for raw material and products, evaluate the quality control and inspection method and work out control plan and inspection instructions for product and materials, take part in the risk management for the new project.
2.Communicate with key suppliers about the parts/components’ quality standard, inspection method, audit the control plan, inspection instructions and other documents from supplier to ensure the supplier take effective quality control.
3.New supplier quality audit and oversee and continue to improve the key suppliers’ quality performance.
4.Train quality inspections and production operators about product quality standard and requirements.
5.Collect and feed the material problems from production line and IQC to suppliers, follow the response of corrective actions and verify the effectiveness of SCAR
6.Analyze and dispose the quality problems in production timely, drive the related dept. to take corrective actions and validate the effectiveness of CAPA.
7.NCR review and disposition for nonconforming product.
8.Audit the final inspection result of IQC and FQC/OQC
9.Participate in the process validation and re-validation, follow up the process, check the quality data &reports and analyze the process capability.
10.Investigate the root cause of customer complaints make corrective actions and reply CAPA
11.Collect the process data, lead or participate relevant quality improvement projects, continue to improve quality control for all projects and increase the customer satisfaction.
12.Participate in the internal audit and assist to improve the process and quality system
13.Other duties assigned by quality manager.
Requirements &Qualification
1.University degree above, major in mechanical equivalent
2.At least 3 years quality engineer experience, must be familiar with injection molding process and assembly, experience in medical device industry about plastic parts is preferred
3.Familiar with various measure tools and instruments, such as calipers, micrometer, profile projector, optical video measure equipment, CMM, etc.
4.Good command at Speaking and written English
5.Familiar with quality tools, such as QC 7 tools, Six sigma, DOE, SPC, MSA, PPAP, APQP and GB2828, etc.
6.Familiar with ISO9001, ISO13485 and FDA 21CFR 820QSR, ISO13485 internal auditor certification is preferred.
7.Excellent problem analysis and solving skills.
8.Good communication and team work, proactive
We will provide the competitive package to excellent candidate, the candidate who has fluent English and abundant quality experience in injection molding in US. or Europe companies is preferred.
特别说明:本岗位有英语、专业技能和相关经验要求,请您仔细阅读。
1.Get involved in the new project quality control from sample stage, communicate with project manager &customer for collecting the overall quality requirements, CTQ and production process for raw material and products, evaluate the quality control and inspection method and work out control plan and inspection instructions for product and materials, take part in the risk management for the new project.
2.Communicate with key suppliers about the parts/components’ quality standard, inspection method, audit the control plan, inspection instructions and other documents from supplier to ensure the supplier take effective quality control.
3.New supplier quality audit and oversee and continue to improve the key suppliers’ quality performance.
4.Train quality inspections and production operators about product quality standard and requirements.
5.Collect and feed the material problems from production line and IQC to suppliers, follow the response of corrective actions and verify the effectiveness of SCAR
6.Analyze and dispose the quality problems in production timely, drive the related dept. to take corrective actions and validate the effectiveness of CAPA.
7.NCR review and disposition for nonconforming product.
8.Audit the final inspection result of IQC and FQC/OQC
9.Participate in the process validation and re-validation, follow up the process, check the quality data &reports and analyze the process capability.
10.Investigate the root cause of customer complaints make corrective actions and reply CAPA
11.Collect the process data, lead or participate relevant quality improvement projects, continue to improve quality control for all projects and increase the customer satisfaction.
12.Participate in the internal audit and assist to improve the process and quality system
13.Other duties assigned by quality manager.
Requirements &Qualification
1.University degree above, major in mechanical equivalent
2.At least 3 years quality engineer experience, must be familiar with injection molding process and assembly, experience in medical device industry about plastic parts is preferred
3.Familiar with various measure tools and instruments, such as calipers, micrometer, profile projector, optical video measure equipment, CMM, etc.
4.Good command at Speaking and written English
5.Familiar with quality tools, such as QC 7 tools, Six sigma, DOE, SPC, MSA, PPAP, APQP and GB2828, etc.
6.Familiar with ISO9001, ISO13485 and FDA 21CFR 820QSR, ISO13485 internal auditor certification is preferred.
7.Excellent problem analysis and solving skills.
8.Good communication and team work, proactive
We will provide the competitive package to excellent candidate, the candidate who has fluent English and abundant quality experience in injection molding in US. or Europe companies is preferred.
特别说明:本岗位有英语、专业技能和相关经验要求,请您仔细阅读。
公司介绍
泛太医疗器械(珠海)有限公司创建于2002年2月16日,座落于中国美丽的滨海城市—珠海,占地约36亩,目前员工约300人,年销售额约3亿人民币。
公司主要生产医疗呼吸设备及配件等10多个系列产品,这些产品主要用于呼吸性疾病急救和麻醉方面,全部出口至美国各大医院并销售至欧洲和东南亚地区。
泛太医疗器械于2013年1月被美国Dempseyventures收购,属于美国Dempseyventures公司全资所有,总部位于美国北卡罗来纳洲,珠海泛太未来将成为Ventlab亚太区的核心工厂和运营中心,目前正在快速发展,需求各种有着丰富经验的专业人才,我们将提供良好的职业发展机会,热忱欢迎您的加入!
公司地址:广东省珠海市斗门区乾务镇乾南工业区珠峰路南新河段6-9号(超群电子旁)
传真:0756-5586998
关于泛太医疗的更多信息,请访问公司网站:
www.ventlab.com
Ventlab Medical device AP Zhuhai found in Feb 16th, 2002, which is locating at the beautiful coastal city Zhuhai, the facility square is a about 36 mu, currently the employees are 300 approximately, turnover is about 300 million RMB.
There are more than 10 serials products currently, these products are mainly used for respiratory
and anesthesia in hospital, all the products 100% exports to in US. Hospital and also sale to Europe and Southeast Asia
Ventlab headquarters in NC. USA and it’s the subsidiary company of Dempseyventures from January of 2013, Zhuhai Factory will be the center of Ventlab Asia pacific, currently we are expediting the development and need diverse professional and experienced talents, we promise to provide the bright and continuous career development opportunity, Welcome to Join us !
Address: No 6 to 9 Nanxin river section, Zhufeng Road, Qiannan Industrial Zone, Qianwu Town, Doumen District, Zhuhai City, PRC.
Fax: +86 (756) 5586998
For more information, please visit the following website of Ventlab corporation:
www.ventlab.com
公司主要生产医疗呼吸设备及配件等10多个系列产品,这些产品主要用于呼吸性疾病急救和麻醉方面,全部出口至美国各大医院并销售至欧洲和东南亚地区。
泛太医疗器械于2013年1月被美国Dempseyventures收购,属于美国Dempseyventures公司全资所有,总部位于美国北卡罗来纳洲,珠海泛太未来将成为Ventlab亚太区的核心工厂和运营中心,目前正在快速发展,需求各种有着丰富经验的专业人才,我们将提供良好的职业发展机会,热忱欢迎您的加入!
公司地址:广东省珠海市斗门区乾务镇乾南工业区珠峰路南新河段6-9号(超群电子旁)
传真:0756-5586998
关于泛太医疗的更多信息,请访问公司网站:
www.ventlab.com
Ventlab Medical device AP Zhuhai found in Feb 16th, 2002, which is locating at the beautiful coastal city Zhuhai, the facility square is a about 36 mu, currently the employees are 300 approximately, turnover is about 300 million RMB.
There are more than 10 serials products currently, these products are mainly used for respiratory
and anesthesia in hospital, all the products 100% exports to in US. Hospital and also sale to Europe and Southeast Asia
Ventlab headquarters in NC. USA and it’s the subsidiary company of Dempseyventures from January of 2013, Zhuhai Factory will be the center of Ventlab Asia pacific, currently we are expediting the development and need diverse professional and experienced talents, we promise to provide the bright and continuous career development opportunity, Welcome to Join us !
Address: No 6 to 9 Nanxin river section, Zhufeng Road, Qiannan Industrial Zone, Qianwu Town, Doumen District, Zhuhai City, PRC.
Fax: +86 (756) 5586998
For more information, please visit the following website of Ventlab corporation:
www.ventlab.com
联系方式
- 公司地址:珠海市斗门区乾务镇乾南工业区珠峰路南新河段6-9号(超群电子旁)
- 邮政编码:519170