Medical Auditor Job at Intertek | Apply Now
Looking for a medical auditor job in India’s growing medical device sector? Intertek is hiring experienced professionals in Bangalore, Chennai, and Hyderabad for a full-time Medical Auditor role. This opportunity is ideal for candidates with strong expertise in ISO 13485, EU MDR, and quality management systems who want to grow in global assurance, testing, inspection, and certification services. If you are exploring Intertek jobs or high-level medicine jobs, this position offers both national and international exposure.
Job details:
- Job Position: Medical Auditor
- Company: Intertek
- Job ID: 13921
- Location: Bangalore Yeshwanthpur, Chennai CSIR Road & Hyderabad
About the Company:
Intertek is a leading Total Quality Assurance provider to industries worldwide. With a network of more than 1,000 laboratories and offices and over 46,000 professionals across more than 100 countries, Intertek delivers innovative and bespoke Assurance, Testing, Inspection, and Certification (ATIC) solutions. Driven by the spirit of its co-founder Thomas Alva Edison, Intertek has led the industry with unparalleled ATIC services for over 130 years. The organization continues to empower professionals to grow within its global quality assurance ecosystem. If you are searching for impactful Intertek jobs, this medical auditor job offers an opportunity to join a heritage brand committed to precision, pace, and passion.
Job Description:
This medical auditor job involves conducting third-party audits of medical device manufacturers in accordance with applicable standards and regulations such as ISO 13485, EU MDR, and MDSAP. The selected candidate will assess compliance of quality management systems, manufacturing processes, design controls, risk management, and post-market surveillance activities. The role requires planning, preparing, and executing audit activities including document reviews, on-site inspections, and remote audits.
Qualifications:
Education:
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Minimum Graduation (Post Graduation preferred) in Medicine or relevant area.
Experience:
- Minimum 5 years of full-time work experience in the medical device industry.
Experience may include: Research and development, Manufacturing, Application of device technology in healthcare services, Testing devices for compliance with national or international standards, Conducting performance testing, evaluation studies, or clinical trials - At least two (2) years must be in Quality Management.
- Prior third-party auditing experience with a notified body is preferred.
Key Responsibilities:
- Conduct third-party audits of medical device manufacturers in accordance with ISO 13485, EU MDR, and MDSAP.
- Assess compliance of quality management systems, manufacturing processes, design controls, and risk management systems.
- Plan and execute audit activities including document reviews, on-site inspections, and remote audits.
- Identify nonconformities and evaluate corrective and preventive actions (CAPA).
- Prepare clear, accurate, and timely audit reports and documentation.
- Maintain impartiality, confidentiality, and professional ethics.
- Stay updated with regulatory changes and industry best practices.
- Communicate audit findings professionally to clients and certification teams.
- Support certification and regulatory approval decisions.
Knowledge & Skills:
- Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR, and MDSAP.
- Understanding of quality management systems, risk management, validation, and manufacturing processes.
- Excellent analytical, report-writing, and documentation skills.
- Strong communication and interpersonal skills.
- Ability to work independently and manage multiple audits.
- Willingness to travel PAN India and internationally.
