QSR Auditor Job At Medline
Medline is looking for an experienced QSR Auditor to assess and strengthen supplier quality systems. This Auditor Job role involves auditing Medline Asia suppliers, ensuring compliance with ISO 13485, FDA regulations, QSR 820, MDR 2017/745, and other global standards. If you have strong knowledge of quality systems and enjoy working closely with vendors to improve compliance, this opportunity is perfect for you. Graduates interested in Pharmacy Jobs and want to build their career in Pharmacy Careers can apply now
Introduction of the Job
The QSR Auditor will audit Medline suppliers, evaluate quality management systems, ensure compliance with global regulations, and support suppliers in corrective actions and improvements.
Job Details for Auditor Job Role:
- Audit Medline Asia suppliers per internal audit SOP and regulations like ISO 13485, FDA regulations, QSR Part 820, MDR 2017/745, ISO 9001, ASTM standards
- Prepare audit reports and support pre-assessment activities
- Conduct CAPA follow-up and evidence review
- Provide guidance and support to vendors for QMS improvements
- Respond to vendor questions, offer instructions, and provide training
- Support pre-audits and follow up with vendors on 3rd-party audit projects
- Assist vendors in addressing audit findings and CAPA review
- Perform tasks related to QMS or supplier audits as assigned
About the Company
Medline is a global healthcare company focused on quality, compliance, and supplier excellence. The team works closely with suppliers across Asia to maintain the highest standards in medical device and healthcare product manufacturing.
Educational Requirements for Auditor Job Role:
-
Pharmacy / M.Pharmacy
Professional Certification
-
ISO 13485:2016 certification (BSI or equivalent) is required
Experience Required for Auditor Job Role:
- Minimum 2+ years in quality audit
- Experience as:
- Third-party medical device auditor OR
- Quality system professional in medical device company OR
- SQE handling supplier audits
- Experience in drug, cosmetic, or laboratory audits is an added advantage
Key Responsibilities for Auditor Job Role:
- Supplier audits
- Audit reporting
- CAPA follow-up
- Vendor training and QMS improvements
- Pre-audit support
- 3rd-party audit coordination
- Compliance with FDA, ISO, and MDR requirements
Skills Required for Auditor Job Role:
- Strong knowledge of ISO 13485, FDA ICH Q7, 21 CFR 210/211, ISO 22716, QSR 820, MDR 2017/745, ISO 9001, ASTM
- Excellent reporting & presentation skills
- Strong time-management & multitasking ability
- Clear communication skills (written & verbal English)
- Ability to analyze details and draw concise conclusions
- Proficiency in office software
How to Apply for Auditor Job Role:
Graduates interested in Pharmacy Jobs and want to build their career in Pharmacy Careers can apply now . Apply through the official Medline Careers Portal for the QSR Auditor position in New Delhi.