Medical Auditor

About the role

Medical Auditor at Intertek Global. Conduct third-party audits of medical device manufacturers in accordance with applicable standards and regulations (e.g., ISO 13485, EU MDR, MDSAP).

What you'll do

• Conduct third-party audits of medical device manufacturers in accordance with applicable standards and regulations (e.g., ISO 13485, EU MDR, MDSAP)
• Assess compliance of quality management systems, manufacturing processes, design controls, risk management, and post-market surveillance activities
• Plan, prepare, and execute audit activities, including document reviews, on-site inspections, and remote audits
• Identify nonconformities, evaluate corrective and preventive actions (CAPA), and verify effectiveness of implemented actions
• Prepare clear, accurate, and timely audit reports and documentation

What you need

• 5–9 yrs of experience
• Audit
• Risk management
• Compliance
• Performance testing
• Clinical research
• ISO 9001
• B.Tech or B.E.

Good to have

• Biology
• Microbiology
• Chemistry
• Physics