长沙招聘

Responsibilities :

- Identifying training needs, teaching employees and supporting Quality for ADC Affiliates in Greater China Proposing new SOPs and amendments as required reflecting changing business practices. 

- Supporting management of local country SOPs. Delivering effective two-way communication between the region, the country management and employees at all levels, to ensure quality improvements are identified and addressed.

- Ensuring region compliance with quality management policies and procedures. 

- Acting as the Quality System expert within the region on quality and compliance, supporting the country’s quality related activities.Supporting new product launches with the Affiliates Supporting the internal process audits and external audits by ADC Headquarters and Notified Body. 

- Assisting the Affiliates in addressing the root causes of audit findings and incidents of non-conformity, thereby assuring the adequacy of corrective and preventive actions. 

- Identifying and implementing process quality measurements to monitor and improve internal processes and promote customer loyalty throughout the region. Reporting regularly to the local, regional, and global management on the effectiveness of the quality management system and assisting in the developing customer and process quality improvement objectives.

- Monitoring the effectiveness of Complaint Handling procedures in the Affiliates, assuring that complaints and customer satisfaction issues are dealt with in a timely and consistent manner. 

- Leading country personnel to ensure incidents and trends of poor quality are identified and escalated when appropriate. 

- Work with the Affiliates to successfully accomplish rework activities; including activity preparations, 3rd party service provided support, releasing goods, and monitoring the activity. 

- Acting as Quality Representative to support cross-functional projects. Supporting implementation of stop shipments, field safety corrective actions, field corrective actions at the regional/local level. 

- Close liaison to local authorities and deal with complex issue from local marketing.

Qualifications:

- The position requires a Bachelors Degree in Chemistry, Physics, Pharmacy, Biology, or Engineering, or the equivalent in experience.

- A minimum of 7 years of experience in the Medical Device or IVD industry is necessary.

- An understanding of the nature of medical devices and in vitro diagnostics is necessary.

- The position also required 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.

- Familiarity with the diagnostics industry is necessary to monitor and develop state-of-the-art quality standards and processes.

- Professional registration and/or certification as appropriate as Lead Auditor.

- ASQ certification such as CQE or CQA is desirable. The ability to speak local languages, e.g. Mandarin as well as English is mandatory.

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：

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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