QSR Auditor 审核员

6 days ago

Shanghai, Shanghai, China 西安麦朗广告有限公司 Full time CN¥120,000 - CN¥180,000 per year

该职位来源于猎聘 RESPONSIBILITIES

  • Audit Medline Asia suppliers per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc..
  • Draft and publish audit reports in high quality and timely
  • Conduct adequate CAPA follow-up and evidence review for supplier in a timely manner
  • Provide supports and guidance for vendors in improving the quality management system per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc..
  • Response to vendors' questions;
  • Necessary instruction, guidance and training for suppliers;
  • Others
  • Support pre audit and support vendors on 3rd party audit project assigned by supervisor/manager (a) Support to conduct pre audit

(b) Support to follow-up with vendors to address the problems identified during the audits (c) Support vendor on CAPA review

  • Other assignments related to Quality Management System, supplier audit or assigned by Manager QUALIFICATIONS
  • Bachelor's Degree.
  • At least 2 years of experience on quality audit.
  • Willing to travel up to 50% of the time for business purposes (domestically and internationally).
  • Fluent both in written and verbal English.
  • Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
  • Solid knowledge of ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc.
  • Strong time management skills. Ability to manage multiple assignments.
  • Good reporting and presentation skills
  • Good communication and cooperation skills
  • Familiar with general office software.

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