Job highlights

- Communicate audit findings to clients,stakeholders,and regulatory or certification teams in a professional manner

- . Support certification,regulatory approval,or surveillance decisions as required.

- Prior third party auditing experience with a notified body is preferred . . .

Key Responsibilities

- 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 transparent, accurate, and timely audit reports and documentation.

- Maintain impartiality, confidentiality, and professional ethics throughout audit activities.

- Stay current with regulatory updates, standards revisions, and industry best practices related to medical devices.

- Communicate audit findings to clients, stakeholders, and regulatory or certification teams in a professional manner.

- Support certification, regulatory approval, or surveillance decisions as required.

Qualifications

Education:

- Minimum Graduation (Post graduation preferred)



in relevant area: biology, microbiology, chemistry, biochemistry, computer/software technology, electrical, mechanical, clinical, biomedical engineering or bioengineering, human physiology, medicine, pharmacy, physics, biophysics, material sciences.

Experience:

- Minimum 5 years of full-time work experience in medical device industry, at one or more of the following:

- closely related industries and the workplace such as research and development, manufacturing.

- the application of the device technology and its use in health care services and with patients;

- testing the devices concerned for compliance with the relevant national or international standards;

- conducting performance testing, evaluation studies or clinical trials of the devices.

- At least two (2) of the five (5) years shall be in the area of quality management.

- Prior third party auditing experience with a notified body is preferred .

- Preferred Industry experience may include experience in one or most of non-active devices for injection, infusion, transfusion and dialysis, anaesthesia, emergency and intensive care, orthopaedic and rehabilitation devices, ophthalmologic devices, surgical instruments, cardiovascular implants, orthopaedic implants, soft tissue implants, Bandages and wound dressings, Suture material and clamps, dental equipment and instruments

📌 Medical Auditor (Bengaluru)
🏢 Intertek
📍 Bengaluru