Auditor - In Vitro Diagnostics Devices

At 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.

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.

Your Tasks

Conduct audits of medical device manufacturers, suppliers, and subcontractors for active medical devices.

Assess compliance against applicable regulatory requirements and standards, including:

ISO 13485

EU-MDR/IVDR

• MDSAP requirements
• Relevant ISO standards for active medical devices
• 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

Your Qualifications

Education

Candidates shall possess one of the following

Bachelor's or Master's Degree in

Biomedical Engineering

Biotechnology

Bioengineering

Medical Laboratory Technology

Biochemistry

Microbiology

Life Sciences

Pharmaceutical Sciences

Chemistry

Clinical Sciences

• Electronics Engineering (with relevant IVD experience)
• Mechanical Engineering (with relevant IVD experience)
• 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

At TÜV SÜD Group, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives.

We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Group Code of Ethics and Company values.

We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD Group. Click here to find out more about Diversity at TÜV SÜD Group.

Work Area

Medical Devices & Healthcare

Country/Region

India

Job Location

Ahmedabad, Bangalore, Delhi, Gurugram, Lucknow, Mumbai, New Delhi, Pune

Working Model

Home-Office

Employment Type

Full time / regular

Company

TUV SUD South Asia Pvt. Ltd.

Org Unit Code

Requisition ID

8128

Duration in months (if limited contract):