Medical Devices Auditor - QMS

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

Job summary

Join a forward-thinking organization dedicated to ensuring patient safety and quality in medical devices. As a Medical Devices Auditor, you will leverage your expertise in High Risk Software and Quality Management Systems to support clients in navigating complex regulatory landscapes. With a commitment to integrity and excellence, this role offers a unique opportunity to contribute to the safety and effectiveness of medical products globally. Enjoy a supportive work environment with comprehensive training, flexible benefits, and a strong focus on career development. Be part of a dynamic team that inspires trust and drives improvement in healthcare.

Benefits

27 days of annual leave

Paid sick leave

Health insurance

Life insurance

Pension plan with company contribution

Car allowance

Income protection

Paid maternity leave

Learning and development opportunities

Flexible benefits

Qualifications

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

Responsibilities

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

Skills

High Risk Software

Quality Management Systems

ISO 13485

Research & Design

Validation

Testing

Servicing

Job description

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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 in 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 in Research & Design, Validation, Testing, or Servicing, combined with experience in Quality Management Systems and an 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, a Notified Body with a history spanning over a century, continues to grow, expand, and uphold our core values of integrity, respect, and expertise, inspiring trust worldwide.

We create structured induction and comprehensive training programs to enable your success. Additionally, we offer tailored learning paths to suit your career development.

Benefits you can expect in the UK

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

Do you believe the world deserves excellence?

We are proud to be the business improvement partner helping organizations become more sustainable and resilient, inspiring 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 over 100 years of experience. We serve over 86,000 companies and organizations across 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cybersecurity expertise across various industries.

As an organization incorporated by Royal Charter, we are impartial and home to the trusted Kitemark.

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

If you are inspired by this 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 reflecting the diversity of our workforce to that of our clients and communities. 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 enjoying meaningful work. BSI is a community where everyone can thrive.

If you require reasonable accommodations during our recruitment process due to a disability or impairment, please inform your Talent Acquisition Partner.

Our Excellence Behaviors: Client-centric, Agile, Collaborative. These behaviors define how we operate at BSI, ensuring it is a great place to work and a successful business.

BSI conducts face-to-face interviews where appropriate. If invited to a face-to-face interview but prefer to conduct it virtually, please discuss this with our recruitment team.