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

We are seeking qualified and experienced Medical Device Auditors to conduct quality management system audits, technical assessments, and compliance evaluations of manufacturers of Active Medical Devices. The role involves assessing conformity with applicable regulatory requirements -and international standards, ensuring that manufacturers maintain effective quality systems and product compliance.

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 IEC and 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 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:

Candidates shall possess one of the following:

• Bachelor's degree or higher in Engineering, Biomedical Engineering, Electrical Engineering, Electronics Engineering, Mechanical Engineering, Mechatronics Engineering, Medical Technology, Physics, Life Sciences, or related scientific disciplines.
• Bachelor's degree or higher in a scientific field relevant to medical device technologies.

Experience

Candidates must meet either of the following requirements:

• Minimum 2-4 years of professional experience in:
• Active Medical Device Manufacturing, and/or
• Quality Assurance (QA), Quality Management, Regulatory Affairs, Design & Development, Production, Testing, Verification, Validation, or related functions within active medical device manufacturing.

• Minimum 2 years of experience working with a Notified Body, Certification Body, Regulatory Authority, or Conformity Assessment Organization involved in assessment, auditing, review, or certification of active medical devices.

Preferred Experience

Experience with one or more of the following technologies:

• Electromedical Equipment
• Diagnostic and Monitoring Devices
• Infusion Systems
• Patient Monitoring Systems
• Imaging Equipment
• Software as a Medical Device (SaMD)
• Active Implantable Medical Devices
• Wearable Medical Technologies
• Other active medical devices

Required Knowledge

• Medical Device Quality Management Systems (ISO 13485)
• Risk Management (ISO 14971)
• Design Control and Product Lifecycle Processes
• Regulatory Requirements for Medical Devices
• Auditing Principles and Techniques
• CAPA and Post-Market Surveillance Activities
• Applicable standards for active medical devices, including IEC 60601 series

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:

• ISO 13485 Lead Auditor
• MDSAP Auditor Training
• Medical Device Regulatory Training
• Quality Management System Lead Auditor Certifications
• Relevant technical certifications in active medical device technologies

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.