苏州招聘

POSITION SUMMARY（职位概述）

Support QMS Manager and work together with the team to maintain and improve quality system compliance as per ISO13485, Corporate requirements and applicable regulation requirements.

KEY RESPONSIBILITIES（主要职责）

1.       Coordinate external audit with QMS manager to have proper arrangement on handling ISO audit, HA audits, customer audits. Be responsible for tracking external audit finding action plan status.

2.       Set-up internal audit plan and oversight the implementation of internal audits. Be responsible for tracking internal audit finding action plan status.

3.       As site CAPA leader maintain CAPA procedure, coordinate CAPA investigation and action plan made, oversight the CAPA status.

4.       Maintain risk management procedure, provide training to process owner to complete necessary risk management report.

5.       Responsible for supplier management, including

ü  New supplier qualification from quality side

ü  Support with supplier routine management, i.e. change request, scorecard.

ü  Set-up annual supplier audit plan and track the completion of audit

ü  Main ASL

6.       Support manager on reviewing and updating quality agreements with BUs.

7.       Fulfill other tasks assigned by manager

SKILLS AND ABILITIES（技能）

1.       Bachelor’s degree on pharmaceutical, medicine, medical device or related subjects

2.       At least 3 years’ experience in quality compliance or related areas in medical device or pharmaceutical

3.       Experience in quality audit and ISO13485 Leader Auditor is preferred

4.       Good communication skills

5.       English fluent in reading, writing, oral and listening

6.       Familiar with routine operations of computer and software

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

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。