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?
1. ■Higher education degree in IT, Biomedical Engineering, Biomechanics, Electronics, Electrical Engineering, Automation, or a related field.
2. ■At least 4 years of professional experience in the development, maintenance, or management of medical devices.
3. ■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.
4. ■Strong interpersonal and communication skills with the ability to build professional relationships.
5. ■Self-motivated, proactive, and detail-oriented.
6. ■Ability to work effectively within a team.
7. ■Willingness to travel frequently, including international business trips.
What we can offer you?
8. ■Hybrid work model and flexible working hours
9. ■Annual bonus subject to company and individual performance
10. ■A package of benefits: private medical care, group life insurance, workplace pension scheme, employee discounts, Salary sacrifice options
11. ■Well being Support
12. ■Work in a friendly, diverse and high-qualified team with positive and cooperative working atmosphere
13. ■International environment and daily usage of foreign languages
14. ■Real development opportunities
15. ■Direct communication and no formal dress code
16. ■Employee referral program
Job Description
17. ■Planning and conducting audits at client sites.
18. ■Preparing comprehensive post-audit documentation and reports.
19. ■Maintaining and developing professional qualifications and certifications.
20. ■Acting as Product Specialist, reviewing clients’ technical documentation for medical devices in accordance with applicable regulatory requirements, standards, and internal procedures.
21. ■Building and maintaining positive, long-term relationships with clients.
22. ■Contributing to the development of new services and participating in strategic growth projects.
23. ■Perform detailed assessments of Quality Management Systems to ensure full compliance with ISO 13485 requirements.
24. ■Identify and document non-conformities while providing clear, evidence-based feedback to clients.
25. ■Act as a subject matter expert during the audit process, ensuring all regulatory requirements for medical devices are met.
We only accept applications submitted online through our application system. We cannot accept applications sent by email.
What else you should know
Job ID19425Type of contractPermanentType of employmentFull TimeWork modelHome Office / fully remoteCompanyTUV Rheinland UK Ltd.
Application deadline: as long as the job is listed on our career page, we are looking for suitable candidates (all genders welcome). We are looking forward to receiving your application.