Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
POSITION SUMMARY:
Product quality management during the design and development. 确保产品研发过程的质量。
Product risk management 产品风险管理
Launched product sustaining by keeping good relationship with OU and other teams 上市后产品维护, 保持与OU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. 在整个产品开发过程中，代表质量保证职能作为产品开发团队的核心成员参与贡献。
Performs: 主导：
Evaluation and documentation of Risk Assessments (ISO 14971). 评估及制定风险管理文档；
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；
Identify and define product Critical-to-Quality (CTQ) characteristics and ensure CTQs are properly validated and controlled throughout the product lifecycle. 识别并定义产品关键质量特性（CTQ），并确保 CTQ 在产品生命周期中得到充分验证和有效控制
Review and approve design documents. 审核及批准设计文档；
Work with Mfg. QE for product successful transfer. 与工厂QE合作进行生产转移。
Participate: 参与：
FMEAs (Design, Process)设计与过程FMEA分析；
Design verification and validation. 设计验证与确认DOE实验设计；
Measurement Systems Analysis. 测量系统分析；
Process Capability Analysis. 过程能力分析；
Process Validation. 过程确认。
NC 不合格品处理
CAPA 纠正和预防措施
Other tasks assigned by manager其他由经理分配的工作任务
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 OU and Mfg. team to ensure appropriate networking and information sharing related to quality activities. 与OU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 MTC on the root cause analysis and action plan for design related customer feedback. 投诉数据统计分析，与MTC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:
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 medical device with software, regulated environment (FDA ISO, etc.) is preferred.
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 ... (truncated, view full listing at source)