Quality Representative, Greater China
上海健臻医疗科技有限责任公司
- 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:2016-12-21
- 工作地点:上海
- 招聘人数:1人
- 学历要求:本科
- 职位月薪:20-30万/年
- 职位类别:质量管理/测试主管(QA/QC主管)
职位描述
职位描述:
1. Performing quality training as needed and providing quality support for regional Quality & Sales and Marketing.
2. Delivering effective two-way communication between the region, Headquarters and the country management & employees at all levels for quality related matters.
3. Ensuring regional compliance with Ascensia Diabetes Care quality management policies and procedures.
4. Acting as the Quality System expert within the region on quality and compliance, supporting the country’s Quality related activities.
5. Monitoring new product and new process introductions to ensure they are adequately planned and documented prior to implementation.
6. Reporting regularly to the regional management on the effectiveness of the quality management system and assisting in the developing customer and quality improvement objectives.
7. Monitoring the effectiveness of Global Event Management and vigilance procedures assuring that complaints and vigilance issues are dealt with in a timely and consistent manner in the countries.
8. Oversight of repackaging and relabeling activities in the countries.
9. Coordinating the conducting of internal process audits and external audits by ADC Headquarters and Health Authorities. Assist the countries in addressing root causes of audit findings and incidents of non-conformity, thereby assuring the adequacy of corrective and preventive actions.
10. Implementing customer satisfaction process and promote customer loyalty through the region.
Qualification:
? The position requires a Bachelor’s Degree in Chemistry, Physics, Pharmacy, Biology, or Engineering, or the equivalent in experience. A minimum of 5 years of experience in the Medical Device or IVD industry is necessary
.? The position also requires a broad understanding and a strong knowledge of the Quality Management Systems applicable to Medical Devices. The incumbent must have a thorough understanding of APAC (specifically China) regulations governing medical devices.
? The position requires strong leadership and persuasion power as it acts as the conscience of Ascensia Diabetes Care in the region. Therefore, it is critical that the incumbent demonstrate good public relations skills within the organization to promote that compliance to Quality Management standards helps rather than hinders profitability
.? The position solves highly complex quality management and technical/professional service issues. This requires a thorough understanding of the Ascensia Diabetes Care’s strategic mission, goals, and objectives in order to support and coordinate the establishment of practices that satisfy regulations and corporate policies
? Professional registration and/or certification as appropriate as Lead Auditor.
? Education or experience in basic quality engineering principles including process control techniques
.?ASQ certification such as CQE or CQA is desirable.? The ability to speak local languages, e.g. Mandarin as well as English is desirable..
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1. Performing quality training as needed and providing quality support for regional Quality & Sales and Marketing.
2. Delivering effective two-way communication between the region, Headquarters and the country management & employees at all levels for quality related matters.
3. Ensuring regional compliance with Ascensia Diabetes Care quality management policies and procedures.
4. Acting as the Quality System expert within the region on quality and compliance, supporting the country’s Quality related activities.
5. Monitoring new product and new process introductions to ensure they are adequately planned and documented prior to implementation.
6. Reporting regularly to the regional management on the effectiveness of the quality management system and assisting in the developing customer and quality improvement objectives.
7. Monitoring the effectiveness of Global Event Management and vigilance procedures assuring that complaints and vigilance issues are dealt with in a timely and consistent manner in the countries.
8. Oversight of repackaging and relabeling activities in the countries.
9. Coordinating the conducting of internal process audits and external audits by ADC Headquarters and Health Authorities. Assist the countries in addressing root causes of audit findings and incidents of non-conformity, thereby assuring the adequacy of corrective and preventive actions.
10. Implementing customer satisfaction process and promote customer loyalty through the region.
Qualification:
? The position requires a Bachelor’s Degree in Chemistry, Physics, Pharmacy, Biology, or Engineering, or the equivalent in experience. A minimum of 5 years of experience in the Medical Device or IVD industry is necessary
.? The position also requires a broad understanding and a strong knowledge of the Quality Management Systems applicable to Medical Devices. The incumbent must have a thorough understanding of APAC (specifically China) regulations governing medical devices.
? The position requires strong leadership and persuasion power as it acts as the conscience of Ascensia Diabetes Care in the region. Therefore, it is critical that the incumbent demonstrate good public relations skills within the organization to promote that compliance to Quality Management standards helps rather than hinders profitability
.? The position solves highly complex quality management and technical/professional service issues. This requires a thorough understanding of the Ascensia Diabetes Care’s strategic mission, goals, and objectives in order to support and coordinate the establishment of practices that satisfy regulations and corporate policies
? Professional registration and/or certification as appropriate as Lead Auditor.
? Education or experience in basic quality engineering principles including process control techniques
.?ASQ certification such as CQE or CQA is desirable.? The ability to speak local languages, e.g. Mandarin as well as English is desirable..
职能类别: 质量管理/测试主管(QA/QC主管)
公司介绍
健臻中国成立于2016年,原为拜耳糖尿病保健业务 。健臻医疗是一个全球性的专业糖尿病领域的医疗器械公司,致力于帮助糖尿病患者。我们的使命是让糖尿病患者通过创新的解决方案,简化和改善他们的生活。我们用我们在糖尿病领域的创新和专业专长发展高质量的解决方案和工具,从而为糖尿病患者创造一个积极的,不同的生活。若您想对公司有更多的了解,可以点击:
********************/cmp/Ascensia-Diabetes-Care
Established in 2016 through the acquisition of Bayer Diabetes Care by Panasonic Healthcare Holdings, Ascensia Diabetes Care is a global company dedicated to improving the health and lives of people with diabetes. Already including the world‐renowned CONTOUR range of blood glucose monitoring systems, we are committed to adding more innovative and life--changing products to our portfolio.
Our goal is to provide products and solutions that make a positive, daily difference for people with diabetes. We want to make sure diabetes doesn't get in the way of people's future, enabling them to live richer lives.
For more than 70 years, continuous research has allowed our diabetes care team to lead the way in blood glucose monitoring systems. These have been developed specifically to meet the needs of patients and along the way we have introduced many firsts.
At Ascensia Diabetes Care we want to serve the needs of patients through our innovation and specialist expertise in diabetes. We create high quality solutions and precision tools that help patients manage their condition and take charge of their lives. Innovation is in our DNA and we are agile, entrepreneurial and dynamic in the way we operate.
We are proud of our heritage as a leading provider of solutions for diabetes care. We are excited by what the future holds and will continue to build on the legacy of our longstanding commitment to diabetes.
To express interest in this job and learn more about Ascensia Diabetes Care click here:********************/cmp/Ascensia-Diabetes-Care
********************/cmp/Ascensia-Diabetes-Care
Established in 2016 through the acquisition of Bayer Diabetes Care by Panasonic Healthcare Holdings, Ascensia Diabetes Care is a global company dedicated to improving the health and lives of people with diabetes. Already including the world‐renowned CONTOUR range of blood glucose monitoring systems, we are committed to adding more innovative and life--changing products to our portfolio.
Our goal is to provide products and solutions that make a positive, daily difference for people with diabetes. We want to make sure diabetes doesn't get in the way of people's future, enabling them to live richer lives.
For more than 70 years, continuous research has allowed our diabetes care team to lead the way in blood glucose monitoring systems. These have been developed specifically to meet the needs of patients and along the way we have introduced many firsts.
At Ascensia Diabetes Care we want to serve the needs of patients through our innovation and specialist expertise in diabetes. We create high quality solutions and precision tools that help patients manage their condition and take charge of their lives. Innovation is in our DNA and we are agile, entrepreneurial and dynamic in the way we operate.
We are proud of our heritage as a leading provider of solutions for diabetes care. We are excited by what the future holds and will continue to build on the legacy of our longstanding commitment to diabetes.
To express interest in this job and learn more about Ascensia Diabetes Care click here:********************/cmp/Ascensia-Diabetes-Care
联系方式
- 公司地址:地址:span长沙