TÜV Rheinland Europe
Medical Device Assessor
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Job Summary
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.
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.
- Performing detailed assessments of Quality Management Systems to ensure full compliance with ISO 13485 requirements.
- Identifying and documenting non-conformities while providing clear, evidence-based feedback to clients.
- Acting as a subject matter expert during the audit process, ensuring all regulatory requirements for medical devices are met.
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What we expect of you?
- 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.
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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 high-qualified team with a 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.
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