QSR Auditor (New Delhi)

Medline Industries, LP; New Delhi; On-site; INR 600,000 - 800,000; Full time

Job summary

A leading medical equipment manufacturer is seeking a Quality Assurance Auditor to oversee supplier quality management systems. Responsibilities include conducting audits, preparing compliance reports, and providing guidance for suppliers. The ideal candidate should have a pharmacy or life sciences background, at least 2 years of relevant experience, and fluency in English. This full-time position may require travel up to 50% of the time.

Qualifications

• At least 2+ years of experience in quality audit.
• Strong knowledge of ISO 13485 and FDA regulations.
• Experience in drug, cosmetic, or laboratory audits considered a plus.

Responsibilities

• Audit Medline Asia suppliers per applicable regulations.
• Prepare audit reports and perform pre‑assessment audit support.
• Conduct CAPA follow‑up and evidence review.
• Support pre‑audit and assistance to vendors on audit projects.

Skills

Quality audit

Fluent English

Time management

Reporting skills

Communication

Education

Pharmacy / M. Pharmacy

Life science background

B.Tech / M.Tech

Job description

Under direct supervision, audit Medline suppliers’ quality management system per applicable regulations.

Core 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, ISO 9001, ASTM standards, etc.
2. Prepare audit reports post‑audit as part of Audit Compliance; perform pre‑assessment audit support; draft and publish audit reports in high quality and timely.
3. Conduct adequate CAPA follow‑up and evidence review for suppliers in a timely manner.
4. Provide support and guidance for vendors in improving the quality management system per Medline internal audit SOP and applicable regulations.
   
   • Necessary instruction, guidance, and training for suppliers;
   • Other activities as required.
5. Support pre‑audit and assist vendors on third‑party audit projects assigned by supervisor/manager.
   
   • Support to conduct pre‑audit.
   • Support to follow‑up with vendors to address problems identified during audits.
6. Other assignments related to Quality Management System, supplier audit, or assigned by manager.

Education

Pharmacy / M. Pharmacy, Life science background, B.Tech / M.Tech. M Pharma OR Biotech/ Bio Medical Engineering.

Certification

BSI (or equivalent) ISO 13485: 2016 certification.

Relevant Work Experience

• At least 2+ years of experience in quality audit.
• Third‑party medical device auditor, or quality system personnel in a foreign‑funded enterprise medical device company, or SQE (Supplier Quality Engineer) responsible for supplier audit in a foreign‑funded enterprise.
• Experience in drug, cosmetic, or laboratory audits considered a plus.

Additional

• Willing to travel up to 50% of the time for business purposes (domestically and internationally).
• Fluent both in written and verbal English.
• Ability to process all relevant details, understand and prioritize their importance, and draw clear conclusions.
• Solid knowledge of ISO 13485, FDA regulations like ICH Q7, 21 CFR 210 & 211, ISO 22716, QSR part 820, MDR 2017/745, ISO 9001, ASTM standards, 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.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Quality Assurance

Industries

Medical Equipment Manufacturing and Pharmaceutical Manufacturing