Medtronic Compliance Engineer in Shanghai, China

Compliance Engineer


Shanghai, Shanghai, China

Requisition #:


Post Date:

6 days ago

  1. Ensure the suitability, adequacy and effectiveness of Quality System. Gap assessment with updated regulations. Identify improvement opportunity of quality system and lead relevant actions.


  1. Arrangement and coordinate external audit from third party inspections.


  1. Responsible for developing and executing the internal audit schedule, identification of areas in need of improvement, and verification of corrective actions.


  1. Maintain the CAPA system, ensure the root cause is identified correctly and the effectiveness of corrective and preventive actions. Ensure the CAPA process goes through in a timely manner.


  1. Report Quality indicator on monthly basis


  • Bachelor of Science degree in Physical Sciences or equivalent本科学历,物理或自然科学或类似背景

  • Mechanical or Electrical education background as a plus机械或电子教育背景优先考虑

  • 2 years working experience in Quality area 2年质量部工作经历

  • experience with multi-national company as a plus具有跨国企业工作经历优先考虑

  • Understand requirements of ISO13485, MDD, and QSR820

理解ISO13485,MDD和QSR820 要求- Understand product registration requirements and process as a plus理解产品注册要求和流程优先考虑

  • ISO 13485 or YY/T0287 internal auditor as plus

具有ISO13485或YY/T0287 内审员资格优先考虑

  • Fluent verbal and written English流利的英语口语和书写

  • Good computer skill of Microsoft application software计算机操作(微软应用程序)