北京招聘

POSITION SUMMARY:

• Product quality management during the design and development through effective communication with BU 与BU进行有效沟通，确保产品研发过程质量

• QMS effectiveness and compliance maintains with high engagement 积极的进行质量体系有效性和符合性维护

• Launched product sustaining by keeping good relationship with BU and other teams 上市后产品维护, 保持与BU及其他团队良好的关系。

PRINCIPal ACCOUNTABILITIES:

¨ Product quality management during the design and development 产品研发过程质量保证： ？ Contributes as a core team member of product development teams representing the QA function throughout the Product Development Process. 在产品研发过程中作为核心成员之一。 ？ Performs: 主导： o Evaluation and documentation of Risk Assessments (ISO 14971). 评估及制定风险管理文档； o Key design tasks lead by QA such as quality plan, customer historical data analysis etc.. QA主导的任务例如质量计划，历史数据分析等； o Review and approve design documents. 审核及批准设计文档； o Work with Mfg QE for product successful transfer. 与工厂QE合作进行生产转移。 ？ Participate: 参与： o FMEAs (Design, Process)设计与过程FMEA分析； o Design verification and validation. 设计验证与确认DOE. 实验设计； o Measurement Systems Analysis. 测量系统分析； o Process Capability Analysis. 过程能力分析； o Process Validation. 过程确认。 ¨ QMS effectiveness maintains: 质量体系有效性维护： ？ Perform internal audit per internal audit plan and participate external audit. 根据内审计划进行内审，并参与外审； ？ Follow up nonconformance report and CAPA to closure. 跟踪不合格评审和CAPA直至关闭； ？ Ensures that all tasks are conducted in accordance with Quality System procedures.确保所有工作符合质量体系的要求； ？ Performs analyses and provide reports to management review as required. 根据需要为管理评审提供分析数据和报告； ？ Other tasks defined in QMS. QMS 定义的其他职责。 ¨ Develop and maintain strong working relationship with GBU and Mfg. team to ensure appropriate networking and information sharing related to quality activities. 与GBU及工厂团队建立并保持良好的合作。 ¨ Launched product sustaining 上市后产品维护 ？ Leading the risk activities after product launched, risk management documentation maintaining and updating 主导上市后产品的风险活动，风险管理文件的维护和更新。 ？ Monitoring and trending possible health risk situations, from post launce sources, and communicating that information to the Manufacturing/Engineering/R&D, and Quality groups 根据上市后的各来源对可能的健康危害监督和趋势统计。并和制造/工程/研发/质量团队进行沟通。 ？ Review the new and revised regulatory requirements for information regarding potentially new hazards and implement related containment actions 审阅新的或修订的法规有关新潜在危害的要求，并实施相关的围堵措施。 ？ Tracking on complaints data, coordinate with respective teams within CTC on the root cause analysis and action plan for design related customer feedback. 投诉数据统计分析，与CTC相应团队一起分析因设计导致的客户投诉的根本原因及行动计划。 ？ Launched product change control, including evaluating change development process and completing related action items identified in the CDP. 上市后产品变更管理，包括评价CDP并完成其识别的相关任务。

EXPERIENCE:

1. Minimum three (3) years’ experience in design, manufacturing, quality assurance or quality engineering position (medical device experience preferred). Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, Risk management, Reliability test, Failure Mode and Effects Analysis. Experience in a regulated environment (FDA ISO, etc.) is preferred.

2. Good communication skills, and good team work. Experience with analytical tools and methods, including statistics (Minitab preferred), DOE. Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485 and 14971 requirements.

EDUCATION:

1. BS/MS is preferred in Mechanical, Medical Device or Electrical engineering background.

2. Influent English in both written and oral.

3. Good computer skill of Microsoft application software.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.