长沙招聘

    KEY RESPONSIBILITIES（主要职责）

1.       Make sure the new project design process meets the NPI procedure

2.       Lead the Human Factor and Risk Management for new projects

3.       Work with team to ensure the design output meets the design input, and ensure evaluation/assessment is data-driven by using in-depth statistical analysis for robust design

4.       Work with manufactory for the Design Transfer, to ensure the manufacturing processes are stable through IQ, OQ &PQ

5.       Supplier audit and management for new projects

6.       Establish & maintain the QMS in China Design Center

7.       Work with Corp. & each Division to ensure the design process meets the Corp. & each Division’s QMS requirements

8.       Ensures compliance with federal and local regulations pertaining to GMP, QSR, ISO, CE and other relevant regulations and policies

9.       Provide training on QM system process as needed

10.    Provide up-to-date training of applicable regulations, guidelines and standards related to Quality assurance

11.    Record and monitor non-conformities during product development. Ensure Root-Cause Investigations are completed, and Corrective Actions are implemented in a timely fashion and track the effectiveness

SKILLS AND ABILITIES（技能）

?           Minimum Bachelor’s degree in Science or Engineering disciplines 

?           Minimum of 5 years in medical device industry

?           Extensive experience with New Product Design Process

?           Hands on experience with quality system management in medical device

?           Familiar with the requirements of GMP, and rich experience of Quality System audit by NMPA

?           Supplier audit experience

?           Solid knowledge in Statistics and hands on experience in using statistic tools

?           Ability to handle critical timelines and multiple tasks at the same time

?           Creative, analytical problem-solving skills

?           Proficient in Microsoft Office Suite and computer-based applications

?           Excellent verbal/written communication skills

?           Written and Spoken English Proficiency

?           Willingness to travel in order to accomplish assignments

DESIRABLE（优先条件）

?           Medical device/Pharmacutical company working experience

?           Design assurance experience

Working conditions & environment(工作状况和条件):

(如是否需要经常出差? Home based?)

1.       Business travel required. 30%

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。