Work as Auditor - In Vitro Diagnostics Devices at TUV SUD Group

TÜV SÜD Group we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group.

Post : Auditor - In Vitro Diagnostics Devices

Position Summary
To conduct audits and assessments of manufacturers of In Vitro Diagnostic Medical Devices (IVDs) against applicable regulatory requirements, quality management system standards, and conformity assessment procedures. The auditor will evaluate compliance with regulations, identify nonconformities, and support certification and regulatory decision-making processes.

Job Description
• Conduct audits of medical device manufacturers, suppliers, and subcontractors for active medical devices.
• Assess compliance against applicable regulatory requirements and standards, including:
o ISO 13485
o EU-MDR/IVDR
o MDSAP requirements
o Relevant ISO standards for active medical devices
o Other relevant standards related to medical devices related standards
• Review technical documentation, design and development processes, risk management files, and post-market surveillance activities.
• Prepare detailed audit plan, audit reports and document findings in accordance with established procedures.
• Evaluate corrective actions and verify effective implementation.
• Participate in audit planning, audit team discussions, and technical reviews.
• Maintain auditor competence through continuous professional development and regulatory training.
• Support technical and certification decision processes as required.
• Client management as customer specialists

Candidate Profile
Candidates shall possess one of the following:
• Bachelor's or Master's Degree in:
o Biomedical Engineering
o Biotechnology
o Bioengineering
o Medical Laboratory Technology
o Biochemistry
o Microbiology
o Life Sciences
o Pharmaceutical Sciences
o Chemistry
o Clinical Sciences
o Electronics Engineering (with relevant IVD experience)
o Mechanical Engineering (with relevant IVD experience)
o Other relevant Engineering or Science disciplines

Experience
Candidates must meet either of the following requirements:
Minimum 2 - 4 years of experience in:
• In Vitro Diagnostic Medical Device manufacturing
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Design and Development
• Production Engineering
• Clinical/Performance Evaluation
• Validation and Verification activities
Minimum 2 years of experience conducting or supporting conformity assessment, certification, technical review, or auditing activities for IVD medical devices within:
• Notified Bodies
• Certification Bodies
• Regulatory Agencies
Preferred Experience
Experience with one or more of the following technologies:
• Molecular diagnostics
• Immunodiagnostics
• Clinical chemistry
• Hematology diagnostics
• Microbiology diagnostics
• Point-of-care testing devices
• Companion diagnostics
• Software used in IVD medical devices
• Sterile IVD products
• Manufacturing process validation
• Risk management according to ISO 14971

Required Knowledge
Strong understanding of :
• ISO 13485 Quality Management Systems
• EU IVDR (Regulation (EU) 2017/746)
• ISO 14971 Risk Management
• Medical device regulatory frameworks
• Auditing principles and techniques
• CAPA systems
• Design and development controls
• Validation and verification methodologies
• Post-market surveillance requirements
• Technical documentation review

Competencies
• Strong analytical and problem-solving skills.
• Excellent report writing and documentation skills.
• Effective verbal and written communication skills in English.
• Ability to work independently and manage multiple audit assignments.
• Professional conduct and integrity.
• Willingness to travel nationally and internationally for audits.

Additional Qualification Preference
The following certifications are advantageous but not mandatory:
• Certified ISO 13485 Lead Auditor qualification
• ISO 19011 auditing knowledge
• MDSAP auditing experience
• IVDR conformity assessment experience
• Regulatory affairs certification
Previous external auditing experience

Additional Information
Experience : 2 - 4 years
Qualification : Bachelor's or Master's Degree
Location : Ahmedabad, Bangalore, Delhi, Gurugram, Lucknow, Mumbai, New Delhi, Pune
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Vitro Diagnostics Devices
End Date : 20th November 2026