Medical Device Assessor

TÜV Rheinland Group; Metropolitan Borough of Solihull; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Private medical care

Group life insurance

Pension scheme

Employee discounts

Well-being support

Job summary

TÜV Rheinland Group is hiring a Medical Device Auditor to ensure compliance with UK and EU regulatory standards. Responsibilities include conducting audits, assessing Quality Management Systems, and preparing documentation. Candidates should have a higher education degree in related fields, at least 4 years of experience in medical devices, and strong QMS knowledge. The position offers a hybrid work model, employee benefits including private medical care, and opportunities for career development.

Qualifications

• Minimum 4 years of experience in medical devices development or management.
• Strong knowledge of UK MDR, ISO 13485:2016, EU MDR.
• Willingness to travel frequently for audits.

Responsibilities

• Planning and conducting audits at client sites.
• Preparing post-audit documentation and reports.
• Reviewing clients’ technical documentation against regulations.

Skills

Quality Management Systems (QMS)

Interpersonal skills

Attention to detail

Self-motivated

Teamwork

Education

Higher education degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, or related field

Job description

Products

In the Products business unit at TÜV Rheinland, we are looking for talents who want to stand with us at the forefront of safety, quality, and innovation. Our goal is to make products safe and compliant with standards in international markets – from consumer goods to highly complex medical devices. In doing so, we support companies in complying with national and international standards.

Our focus is on the challenges of digitalization, sustainability, and global trade requirements. Whether smart technologies, sustainable materials, or the safety of connected products – we actively shape the future of product safety.

Our Core Areas

• Softlines: Testing, inspection, and certification services for textiles, clothing, footwear, leather goods, and other consumer products.
• Hardlines: Safety and quality testing for household goods, toys, furniture, sports equipment, tools, and DIY products.
• Electrical: Testing and certification of electrical and electronic products, from household appliances to industrial control systems.
• Solar & Commercial: Quality assurance and certification of photovoltaic modules, inverters, and commercial technical installations.
• Medical: Comprehensive testing and certification for medical devices, from diagnostic equipment to implants, including regulatory consulting.

Job Summary

Seeking a Medical Device Auditor to conduct client audits, assess Quality Management Systems, and ensure compliance with UK and EU regulatory standards. The role involves reviewing technical documentation, identifying non-conformities, and building strong client relationships.

What we expect of you

• Higher education degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, Automation, or a related field.
• At least 4 years of professional experience in the development, maintenance, or management of medical devices.
• Strong knowledge of Quality Management Systems (QMS) for medical devices and familiarity with regulations (UK MDR [MHRA], UK IVDD [MHRA], ISO 13485:2016 [UKAS], EU MDR and EU IVDR) is highly desirable.
• Strong interpersonal and communication skills with the ability to build professional relationships.
• Self‑motivated, proactive, and detail‑oriented.
• Ability to work effectively within a team.
• Willingness to travel frequently, including international business trips.

What we can offer you

• 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 highly 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

Job Description

• 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.

Benefits

• 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!