Medical Devices Auditor - QMS

TN United Kingdom; Cardiff; On-site; GBP 40,000 - 70,000; Full time

Job summary

Join a forward-thinking organization as a Medical Devices Auditor, where your expertise in High Risk Software will play a crucial role in enhancing patient safety. This position offers the opportunity to work with a dynamic team dedicated to ensuring compliance and quality in medical devices across Europe. With a commitment to integrity and excellence, this established firm provides comprehensive training and a supportive environment for professional growth. If you are passionate about making a difference in healthcare and have the skills to drive quality assurance, this role is perfect for you.

Benefits

27 days annual leave

Paid sick leave

Health and life insurance

Pension plan with company contribution

Car allowance

Income protection

Paid parental and adoption leave

Flexible benefits

Learning opportunities

Qualifications

• Technical expertise in High Risk Software medical devices.
• Experience with Quality Management Systems and ISO Standards.

Responsibilities

• Contribute to patient safety and support market access for medical devices.
• Conduct audits and ensure compliance with ISO standards.

Skills

High Risk Software

Quality Management Systems

ISO 13485

Research & Design

Validation

Testing

Servicing

Job description

Job Opportunity: Medical Devices Auditor (UK & Europe)

Great that you're considering a career with BSI!

Position: Medical Devices Auditor

Location: UK (with travel in Europe). We are also open to applications from candidates based in other European countries outside the UK.

About the Role

Our EIMEA Medical Devices Auditing Team is interested in talented individuals, especially those experienced with High Risk Software. We are also open to profiles with diverse Medical Devices experience.

About You

You should have technical expertise in High Risk Software medical devices, including Research & Design, Validation, Testing, or Servicing. Additionally, experience with Quality Management Systems and knowledge of ISO Standards, particularly ISO 13485, are important.

Why Join Us?

Join our Medical Devices team to contribute to patient safety and support timely market access for medical device products globally. BSI, a Notified Body with over a century of history, values integrity, respect, and expertise, and aims to inspire trust.

We offer structured induction and comprehensive training programs, along with tailored learning paths to support your career growth.

Benefits in the UK

• 27 days annual leave
• Paid sick leave
• Bank holidays
• Health and life insurance
• Pension plan with company contribution
• Car allowance (role-dependent)
• Income protection
• Paid parental and adoption leave
• Flexible benefits and learning opportunities

Our Mission

We aim to improve business sustainability and resilience, inspiring trust in products, systems, and services worldwide. Headquartered in London, BSI is the world's first national standards organization, serving over 86,000 companies across 193 countries, offering certification, auditing, training, and innovative solutions.

Join Our Team

If you are enthusiastic about making a difference, bring your mindset to our dynamic team. Apply now and become part of the BSI family!

Diversity & Inclusion

BSI is committed to reflecting the diversity of our communities and providing opportunities for growth and engagement. We accommodate reasonable adjustments during the recruitment process for individuals with disabilities or impairments.

Our core behaviors are Client-centric, Agile, and Collaborative, ensuring BSI remains a great place to work and a successful business.

Interview Process

We conduct face-to-face interviews where appropriate. If you prefer virtual interviews, please discuss this with our recruitment team.