TÜV Rheinland Group
Medical Device Assessor
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Medical Device Assessor
Products – Medical Device Assessor / Auditor
At the Products business unit of TÜV Rheinland, we seek passionate individuals ready to contribute to the forefront of safety, quality, and innovation. Our mission is to ensure products adhere to national and international standards across global markets, from consumer goods to complex medical devices.
With a focus on digitalization, sustainability, and global trade requirements, we actively shape the future of product safety—whether it’s smart technologies, sustainable materials, or connectivity. Here’s how you can be part of this mission:
Our Core Areas
- Softlines: Testing, inspection, and certification for textiles, footwear, leather goods, and consumer products
- Hardlines: Safety and quality testing for household items, toys, furniture, tools, and DIY products
- Electrical: Certification of electrical and electronic products, from appliances to industrial systems
- Solar & Commercial: Quality assurance for photovoltaic modules, inverters, and technical installations
- Medical: Comprehensive testing and medical device certification (diagnostics to implants)
About the Role
As a Medical Device Assessor / Auditor, you’ll play a pivotal role in ensuring regulatory compliance and safety in the medical device industry.
Key Responsibilities
- Conduct audits at client sites, assessing:
- Design, manufacture, testing, and quality control of medical devices
- Compliance with ISO 13485 standards
- Evaluating Quality Management Systems (QMS)
- Prepare comprehensive post-audit documentation and reports
- Perform detailed assessments, identifying and documenting non-conformities and providing clear feedback
- Act as a Product Specialist, reviewing technical documentation in alignment with:
- Applicable regulatory requirements (e.g., UK MDR, UK IVDD, EU MDR, EU IVDR)
- Internal TÜV Rheinland procedures
- Develop new services and participate in strategic growth projects
- Foster and maintain long-term client relationships
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Requirements
You are the ideal candidate for this role if you meet the following criteria:
- A higher education degree in one of these technical/scientific fields:
- IT, Biomedical Engineering, Biomechanics
- Electronics, Electrical Engineering, Automation (or related disciplines)
- At least 4 years of professional experience in the medical device industry, including:
- Design, manufacture, testing, or quality control (with at least 2 years in one of these core areas)
- Practical understanding of:
- Medical device development, production, testing, or clinical/user applications
- Knowledge of:
- ISO 13485:2016 Quality Management Systems (desirable)
- Familiarity with regulatory frameworks (UK MDR, UK IVDD, EU MDR, EU IVDR) is a plus—training can be provided
- Strong interpersonal and communication skills, with the ability to build trust-based client relationships
- Self-motivated, proactive, and detail-oriented
- Willingness to travel frequently, including international assignments
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What We Offer
TÜV Rheinland doesn’t just stand for excellence—it’s built by a team that learns, grows, and collaborates. You’ll enjoy:
✅ Flexible Hybrid Work Model with flexible hours ✅ Annual bonus, based on team and individual performance ✅ Comprehensive benefits, including:
- Private medical care
- Group life insurance
- Workplace pension scheme
- Employee discounts and salary sacrifice options ✅ Well-being support, valuing both physical and mental health ✅ Positive, diverse, high-quality workplace ✅ International environment with daily use of foreign languages ✅ Development opportunities and career growth ✅ Informal yet productive culture with no formal dress code ✅ Employee Referral Program ✅ And so much more!
Why work with us?
TÜV Rheinland isn’t just a noted heritage company—we shape a safer, smarter future with our employees. Here, work is personal, and our pride lies in enlargement collective potential.
Join us and help pioneer a future where safety, quality, and innovation intersect.
Eligible candidates are encouraged to submit their applications. Your journey starts now.
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