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.