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.