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Job Responsibilities:
1. 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..
2. Draft and publish audit reports in high quality and timely
3. Conduct adequate CAPA follow-up and evidence review for supplier in a timely manner
4. 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..
a. Response to vendors questions;
b. Necessary instruction, guidance and training for suppliers;
c. Others
5. 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
6. Other assignments related to Quality Management System, supplier audit or assigned by Manager
Qualifications:
1. Education: Bachelor's Degree.
2. Relevant Work Experience: Third-party medical device auditor, or quality system personnel in a foreign-funded enterprise medical device company, or SQE (Supplier Quality Engineer) who is responsible for suppler audit in a foreign-funded enterprise. Having experience in drug, cosmetic, or laboratory audits will be considered a plus.
3. Willing to travel up to 50% of the time for business purposes (domestically and internationally).
4. Fluent both in written and verbal English.
5. 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.
6. Strong time management skills. Ability to manage multiple assignments.
7. Good reporting and presentation skills
8. Good communication and cooperation skills
9. Familiar with general office software.
Job ID: 138837565
Skills:
Ms Office Applications, English Speaking, ISO 45001 Occupational Health Safety Management System, ISO 14001 Environmental Management System, ISO 9001 Quality Management System
Skills:
resources management , Integration, Software Development, System Architecture, Quality Assurance, Process Development, Root Cause Analysis, Compliance, Continuous Improvement, Stakeholder Communication, Vendor Management, Strategic Planning, Risk Management, Leadership And Management, Stakeholder Engagement, Incident Leadership, Project Management, Technical Support, Innovation and Improvement
Skills:
Quality Management Systems, Wastewater treatment system operations, Iso 9001, Iso 14001, Product quality analysis, ISO 45001, Quality Control, Continuous improvement methodologies, Corrective and preventive actions
Skills:
Iso 14971, Iso 13485, Iso 9001, Microbial monitoring, Sterilization validation, Corrective action Preventive action program, Bioburden testing, ISO 11137, Microsoft Word, Risk Analysis, ISO 11135
Skills:
recruitment marketing , Resume Screening, Quality Management System, Sourcing, Recruitment, Interviewing