苏州招聘

POSITION SUMMARY（职位概述）

?     Responsible for change coordination and control for one or multiple worldwide business platforms in compliance with FDA, ISO and other applicable regulations.

    

?     Responsible for administering all activities in the document control function. Provides quality system support to the department.  Maintains a document management system that complies with quality and regulatory requirements.  Leads continuous improvement efforts for documentation.  Capable of taking broad work assignments requiring minimal supervision. 

    

?     Facilitates the engineering change management and material master data workflow processes, ensuring complete, consistent implementation of changes within and across business platforms and manufacturing plants worldwide.

    

?     Possesses a broad business perspective, supporting platform core teams in global new product design and development as well as sustaining projects, combined with in-depth understanding of BD’s ERP and engineering change control environment (SAP PLM)

    KEY  RESPONSIBILITIES（主要职责）    

1.       Quality System

    

ü  Acts as Document Coordinator in ISO 13485/FDA QSR/GMP and ISO17025 Quality System environment.

    

ü  Acts as Engineering Change Coordinator for Documentation Management System (ECC).

    

ü  Maintains document archival and record retention program.

    

ü  Participates in the coordination, review, approval of new documents, and document revision.  Ensure that all documentation are accurate, up-to-date, and available to appropriate personnel.

    

ü  Ensures that documents are revised, approved, and well maintained and ensures that controlled copies are available at the authorized locations.

    

ü  Issues and controls the numbering system of documents according to various types of document.

    

ü  Performs review of each document submitted for change/ review to ensure compliance with existing procedures; identifies affected documentation and defines appropriate action.

    

ü  Supports site documentation and change control users as subject matter expert (SME).

    

ü  Leads audit support activities for the site during internal/ external audits.

    

ü  Writes/ revises documentation procedures to support the business and quality/regulatory requirements.

    

ü  Implements error proofing concepts throughout the document control lifecycle.

    

ü  Authorized to destroy, or archive obsolete controlled copies of documents and responsible for the retention and storage of obsolete documents.

    

ü  Maintains effective Quality System and procedures to ensure that all documentation are controlled and updated per established corporate, national, and international regulatory guidelines as well as Good Documentation Practices.

    

ü  Maintains contacts with BD Division, R&D, Corporate, Medical, Quality, and Documentation Coordinators of all BD Medical manufacturing

    

2.       Product Development

    

ü  Ensures projects documentation complies with Quality System requirements i.e. coordinating documentation of specifications, ECOs, PDN, and forms.

    

ü  Participates in projects to provide assistance in documentation

     

 SKILLS AND ABILITIES（技能）

1.       Degree in business, information systems, engineering or technical discipline

    

2.       Basic understanding of quality system regulations and standards.

    

3.       Attention to detail, careful, deliberate, disciplined, meticulous.

    

4.       Effective organizational and planning skills.

    

5.       Team player with excellent written and oral communication skills.

    

6.       Knowledge of medical device regulations and practices (ISO 13485, FDA QSR, GMP etc.).

    

7.       General SAP use, Engineering Change Management.

    

8.       Solid computer skills in MS Office and other reporting tools.

    

9.       Demonstrated ability to quickly learn new subject matter

    

10.    3-4 years relevant experience in ISO/ FDA regulated environment, with exposure to document and data control processes like engineering change control, label and copy approval, etc. is required

    

11.    1-2 years’ experience utilizing electronic change control tools is required

    

DESIRABLE（优先条件）

    

1.       Experience of ISO17025 documentation role

    

2.       Medical device company working experience

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。