Auditor - Medical Devices (Active Devices)

Key ResponsibilitiesConduct 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.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.QualificationsEducation: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 active devices extra-corporal circulation, infusion and hemapheresis, respiratory devices, active surgical devices, active ophthalmologic devices, active non-implantable devices for ear, nose and throat, active dental devices, active devices for disinfection and sterilization, active devices for patient positioning and transport, medical gas supply systems and parts thereof, Imaging devices utilizing ionizing and non- ionizing rays, Monitoring devices of non-vital and vital physiological parametersTrainingMust have completed 5 Days IRCA approved Lead auditor programme or equivalent for ISO 13485 and/or ISO 9001:2015Desired to have 40 hours initial training on general aspects ofthe MDR including general safety and performance requirements (Annex I), relevant harmonized standards, including risk management (EN ISO 14971), Common Specifications and guidance documents and verified by relevant test (as applicable). Training before joining Intertek can count toward this.Knowledge & Skills:Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR, 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 as required – PAN India and InternationalWorking ConditionsCombination of office-based work, remote audits, and on-site facility audits.Domestic and/or international travel will be required.

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