We are looking for a Medical Device Assessor / Auditor with a background in medical device designing manufacturing, or quality control. Candidates must have at least 4 years’ professional experience in one or more of these areas, of which at least 2 years must be directly related to the design, manufacture, testing, quality control, or use of the medical device or technology being assessed.
-
Planning and conducting audits at client sites.
-
Preparing comprehensive post-audit documentation and reports
-
Maintaining and developing professional qualifications and certifications.
-
Acting as Product Specialist, reviewing clients’ technical documentation for medical devices in accordance with applicable regulatory requirements, standards, and internal procedures.
-
Building and maintaining positive, long-term relationships with clients.
-
Contributing to the development of new services and participating in strategic growth projects.
-
Perform detailed assessments of Quality Management Systems to ensure full compliance with ISO 13485 requirements.
-
Identify and document non-conformities while providing clear, evidence-based feedback to clients.
-
Act as a subject matter expert during the audit process, ensuring all regulatory requirements for medical devices are met.
-
Higher education degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, Automation, or a related technical/scientific field.
-
At least 4 years of professional experience gained in the medical device industry, particularly in the design, manufacture, testing, quality control, or use of medical devices or related technologies.
-
Practical understanding of medical device development, production, testing, quality control, or clinical/user application.
-
Knowledge of Quality Management Systems for medical devices, particularly ISO 13485:2016, is desirable.
-
Familiarity with applicable medical device regulations, including UK MDR, UK IVDD, EU MDR and EU IVDR, is desirable but can be further developed internally.
-
Strong interpersonal and communication skills, with the ability to build professional relationships with clients and colleagues.
-
Self-motivated, proactive, and detail-oriented.
-
Ability to work effectively within a team.
-
Willingness to travel frequently, including international business trips.
-
Hybrid work model and flexible working hours
-
Annual bonus subject to company and individual performance
-
A package of benefits: private medical care, group life insurance, workplace pension scheme, employee discounts, Salary sacrifice options
-
Well being Support
-
Work in a friendly, diverse and high-qualified team with positive and cooperative working atmosphere
-
International environment and daily usage of foreign languages
-
Real development opportunities
-
Direct communication and no formal dress code
-
Employee referral program
- Positive working atmosphere: Isn't it tempting to work for an established, significant company with a rich heritage? Here's the even better news: we also want the work to be fun!
- Employee events: Building. Memories. Together. Various events for employees await you!
- Employee discounts: Exclusive employee offers at attractive conditions are just one of the great benefits we offer you. Please enquire about the details in a personal meeting.
- Bonus programmes: We believe in rewarding performance by recognising success. Let's talk about the details of our bonus programmes in a personal meeting.
- Experienced and international teams: We welcome new talent, but are also proud of our many long-standing colleagues. Let your personal experience come together with our multicultural TÜV Rheinland experience to achieve something together!
- Insurance packages and health care: We are proud to save lives with our work. The physical and mental well-being of our employees is just as important to us! We would be happy to inform you about our insurance and health packages in a personal meeting
- Employee training and development: We live ‘Just right’ as the core of our corporate DNA. Constantly growing together and learning from each other is therefore a matter of course for us!
In the Products division at TÜV Rheinland, we are looking for talented individuals who want to join us at the forefront of safety, quality, and innovation. Our goal is to ensure that products on international markets are safe and compliant with standards—from consumer goods to highly complex medical devices. In doing so, we help companies meet national and international standards.
Equal opportunities are particularly important to us at TÜV Rheinland. We are committed to breaking down barriers and creating an inclusive working environment characterised by respect, diversity and genuine participation. We therefore particularly welcome applications from people with severe disabilities.
Join a strong team! At TÜV Rheinland, you can apply and expand your expertise in an international setting. We offer a dynamic work environment that fosters innovation and is committed to diversity and continuous learning. Together, we are shaping a future where safety and quality go hand in hand.
