Career Opportunities: Medical Device Auditors (19425)

Requisition ID 19425 - Posted 

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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 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

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.

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