Medical Devices Auditor - QMS

TN United Kingdom; London; Hybrid; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Medical Devices Auditor to join their dynamic team. This role focuses on ensuring compliance with high-risk software medical devices and involves conducting audits across Europe. You will play a crucial part in supporting patient safety and facilitating market access for innovative medical products. With a commitment to integrity and excellence, this organization offers comprehensive training and a supportive work environment. If you are passionate about making a difference in the medical field, this opportunity is perfect for you.

Benefits

27 days of annual leave

Paid sick leave

Health and life insurance

Pension contributions

Car allowance

Income protection

Paid parental leave

Learning opportunities

Flexible benefits

Qualifications

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

Responsibilities

• Conduct audits for medical devices ensuring compliance with standards.
• Support patient safety and timely market access for medical products.

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 thinking about a career with BSI!

Position: Medical Devices Auditor

Location: UK (with travel in Europe)

We are also open to applications from candidates based in European countries outside of the UK.

About the Role

Our EIMEA Medical Devices Auditing Team is interested in talented individuals, particularly those experienced with High Risk Software medical devices. We are also open to profiles with different Medical Devices expertise.

About You

We seek professionals with technical expertise in High Risk Software medical devices, including Research & Design, Validation, Testing, or Servicing. Experience with Quality Management Systems and knowledge of ISO Standards, especially ISO 13485, is essential.

Why Join Us?

Our Medical Devices team ensures patient safety and supports timely market access for medical device products globally. BSI, a Notified Body with over a century of history, continues to grow while upholding our core values of integrity, respect, and expertise — inspiring trust.

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

Benefits in the UK

Enjoy 27 days of annual leave, paid sick leave, bank holidays, health and life insurance, pension contributions, car allowance (role-dependent), income protection, paid parental and adoption leave, compassionate and bereavement leave, learning opportunities, and flexible benefits tailored to your lifestyle.

Our Mission

We aim to make the world better through excellence. As a business improvement company, we help organizations become more sustainable and resilient, inspiring trust in their products, systems, and services.

About BSI

Headquartered in London, BSI is the world's first national standards organization with over 100 years of experience. We serve 86,000+ companies across 193+ countries, offering development, auditing, certification, and training services, including software solutions and cybersecurity expertise across various industries.

As a Royal Charter organization, we are impartial and proud to hold the Kitemark, the ultimate mark of trust.

Join Our Team

If you're ready to contribute to our inspiring mission, bring your enthusiasm and open mindset—apply now to become part of the BSI family!

Diversity & Inclusion Policy

We are committed to reflecting the diversity of our communities and creating a sense of belonging for all employees. We provide opportunities for growth and engagement within our global organization. If you need accommodations during the recruitment process due to a disability or impairment, please inform your Talent Acquisition Partner.

Our Core Behaviors

Client-centric, Agile, Collaborative — these behaviors define how we operate at BSI, ensuring a great workplace and business success.

Interview Process

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