长沙招聘

POSITION SUMMARY

The position is responsible for the quality system maintenance and continuous improvement related with distribution center operation to ensure Quality System to meet ISO13485, China GSP and applicable regulatory requirement as well as Corporate Policy.

  KEY RESPONSIBILITIES

1.       Develop distribution center quality system, partner with cross functions and implement a unified quality system for the distribution centers/3PLs, to ensure comply with ISO13485, China GSP and corporate policy.

2.       Distribution center’s data collection, analysis and trend monitoring, quality metrics reviewing, to identify continuous improvement opportunity and take actions to driven improvement.

3.       Partnering with the SCM to Monitoring 3PL supplier’s performance per the performance mechanism.

4.       Change management, Non-conformance handling including coordinate the disposition to ensure non-conforming products management and prevent unintended release.

5.       Provide training to improve Distribution center’s quality management ability.

6.       Chinese Label/IFU content review against applicable stand and approval.

7.       Coordinate the on-site resource and ensure product timely released after sub-labeling. 

8.       Partner with business to address business request and demand regarding Distribution center quality.

9.       Provide support on Distribution center quality related projects.

10.    Coordinate and support distribution center’s audit, including internal audit, customer audit or NMAP and other post market authority surveillance audit.

11.    Other related work assigned by the supervisor.

SKILLS AND ABILITIES

1.      At least 3 years’ quality assurance experience in the pharmaceutical or medical device

2.      Relevant experience in quality systems for failure investigation, corrective & preventive action, and document & quality records management.

3.      Experience in trading company, supply chain/warehouse quality systems  

4.      Fluent in spoken and written English.

5.      Drive for results and action oriented with a high sense of urgency

6.      Good communication skills

7.      Teamwork

DESIRABLE

1.       Bachelor’s degree or above in Pharmacy Chemistry or other related major Science discipline.

2.       Medical Device/ Engineering working experience is preferred.

3.       Familiar with the medical device related regulatory related with quality system requirements, e.g. GMP, GSP, Recall, Chinese label requirements etc.

4.       Knowledge in ISO 9000:2008, ISO 13485:2003 or US FDA QSR will be an advantage.

5.       Certified 6 Sigma black belt will be an advantage

6.       Good English communication skills, computer skills, Microsoft etc.

Travel Frequency

  0   <25%        √ 25%-50%   50%-75%   >75%  

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.

关于BD

BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者，致力于通过研发创新技术、服务和解决方案，帮助患者改善临床治疗，并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念，致力于帮助提升患者的治疗效果，为临床医护人员提供安全、高效的护理给药流程，协助实验室科学家们更有效地诊断疾病，并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构，与全球范围内的组织机构积极合作，携手应对最具挑战的全球健康问题。通过与客户的紧密协作，BD以改善治疗结果，降低医疗成本，提升诊断效率为己任，帮助加强患者和医护人员的安全并扩大医疗可及性。2017年，BD欢迎巴德及其产品加入BD大家庭。更多信息，敬请访问**********/china。