Medical Devices Auditor - QMS

TN United Kingdom; Cambridge; On-site; GBP 35,000 - 65,000; Full time

Job summary

An established industry player is seeking a Medical Devices Auditor to join their dynamic team in Cambridge. This role involves ensuring patient safety and compliance for high-risk software medical devices while supporting timely market access for clients. The ideal candidate will have a strong background in Quality Management Systems and ISO standards, particularly ISO 13485. With a commitment to integrity and expertise, the company offers a structured induction and tailored learning paths to foster career growth. Join a team that values diversity and excellence, and contribute to inspiring trust in medical products globally.

Benefits

27 days annual leave

Paid sick leave

Health insurance

Life insurance

Pension plan with company contribution

Car allowance

Income protection

Paid maternity leave

Paid paternity leave

Learning and development opportunities

Qualifications

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

Responsibilities

• Ensure patient safety while supporting timely market access for medical devices.
• Conduct audits and ensure compliance with ISO 13485 standards.

Skills

High Risk Software

Quality Management Systems

ISO Standards

Research & Design

Validation

Testing

Servicing

Job description

Social network you want to login/join with:

Medical Devices Auditor - QMS, Cambridge

Client:

BSI

Location:

Cambridge, United Kingdom

EU work permit required:

Yes

Job Reference:

33824ed31514

Job Views:

33

Posted:

11.04.2025

Expiry Date:

26.05.2025

Job Description:

Great that you're thinking about a career with BSI!

Medical Devices Auditor
UK (with Travel in Europe)

Happy to also consider applications from those who are based in European countries outside of the UK.

Our EIMEA Medical Devices Auditing Team is always interested in speaking with talented individuals. We are particularly interested in individuals with experience of High Risk Software, however, we are equally interested in profiles with different Medical Devices.

About you

We are looking for someone with technical expertise in High Risk Software medical devices, whether that is Research & Design, Validation, Testing, or Servicing, combined with working experience of Quality Management Systems and understanding of ISO Standards, especially ISO 13485.

Why should you join us?

Our Medical Devices team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is a Notified Body with a history spanning over a century, and we continue to grow, expand, and adhere to our core values of integrity, respect, and expertise to continue “inspiring trust.”

We create structured induction and full training programs to enable your success. In addition, we provide tailored learning paths to suit your career needs.

Benefits you can expect in the UK:

27 days annual leave, paid sick leave, bank holidays, health insurance, life insurance, pension plan with company contribution, car allowance (dependent on role), income protection, paid maternity leave, paid paternity leave, paid parental leave, adoption leave, compassionate leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.

Do you believe the world deserves excellence?

We are proud to be the business improvement company for other organizations to become more sustainable and resilient and to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cybersecurity expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT, and trade sectors. Incorporated by Royal Charter, we’re truly impartial and home to the ultimate mark of trust, the Kitemark.

Through our unique combination of consulting, training, assurance, and regulatory services, we bring solid and broad knowledge to every company.

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization, all while having fun doing great work. BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability or impairment throughout our recruiting process, please inform your Talent Acquisition Partner.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable conducting the interview virtually, please speak to a member of our recruitment team.