Medical Auditor
Intertek · Bengaluru
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 46,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely. True to the spirit of our founders, we lead the industry with unparallel ATIC services. The spirit ignited by our co-founder Thomas Alva Edison who gave one of the biggest inventions to the world - lightbulb, has guided all the Intertekers for 130 years and we continue to discover the Edison in ourselves every day! The opportunity for you to be a part of this heritage is right there, join our ever-better journey it’s time to unveil your destiny.
What we are looking for in you?
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 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.
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
Training
Must have completed 5 Days IRCA approved Lead auditor programme or equivalent for ISO 13485 and/or ISO 9001:2015
Desired to have 40 hours initial training on general aspects of
the MDR including general safety and performance requirements (Annex I), relevant harmonised 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 International
Working Conditions
- Combination of office-based work, remote audits, and on-site facility audits.
- Domestic and/or international travel will be required.
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