-
3-4年经验 -
本科 -
招1人 -
03-02 发布
职位描述
PRINCIPAL ACCOUNTABILITIES: 1. Contributes as a core team member of product development teams representing the QA function throughout the Product Development Process. 2. Key tasks lead by QA: - Risk management plan, risk analysis, risk management reports based on ISO14971 - CTQ. - Quality Plans. - Customer complaint historical data - Quality system for design and development 3. Performs: - Support other design and development tasks, such as FMEA (Design, Process, and Application), Process validation, Measurement Systems Analysis, Design verification and validation etc - Review and approve design documents and change control as core team member - Work with Mfg QE for product successful transfer. - Maintain quality system for design and development 4. Contributes to the successful completion of Process Validation initiatives: - Participate in pilot line set up and trial run. - Participate in the preparation of IQ, OQ, and PQ protocols and report - Perform statistical analysis of process data; interpret, compile and organize results and reports. 5. Lead nonconformance report and CAPA 6. Ensures that all tasks are conducted in accordance with Quality System procedures. 7. Collect, analyze and interpret statistical data. 8. Performs analyses and provide reports to management as required. 9. Involve in QMS improvement and internal audit. 10. Improve quality culture in project team. Provide QA training and case sharing with project team.EXPERIENCE:-Minimum three (3) years’ experience in design 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 (ISO,MDD etc.) is preferred -BS/MS is preferred in Material, Software, Mechanical or Electrical engineering background-Influent English in both written and oral. -Good computer skill of Microsoft application software 职能类别： 医疗器械生产/质量管理 关键字： 医疗器械 质量控制 工程师 质量管理 QA
联系方式
上海
公司信息
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.
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