QMS Medical Devices Auditor - High Risk Software

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

Job summary

An established industry player is seeking a Medical Devices Auditor specializing in High Risk Software. This role involves ensuring compliance with ISO standards and contributing to patient safety in the medical device sector. With a commitment to integrity and expertise, the company offers a collaborative environment and structured training programs. The position includes opportunities for travel across Europe, making it ideal for those passionate about quality management in healthcare. Join a team that values excellence and supports your career development with tailored learning paths and flexible benefits.

Benefits

27 days of annual leave

Paid sick leave

Health and life insurance

Pension plan with company contribution

Car allowance

Income protection

Paid maternity and paternity leave

Learning and development opportunities

Flexible benefits tailored to your lifestyle

Qualifications

• Technical expertise in High Risk Software medical devices.
• Experience with Quality Management Systems and ISO 13485.

Responsibilities

• Ensure patient safety and support timely market access for medical devices.
• Conduct audits and assessments for compliance with 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:

QMS Medical Devices Auditor - High Risk Software, Leeds

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Client:

BSI

Location:

Leeds, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3140d2266450

Job Views:

14

Posted:

29.04.2025

Expiry Date:

13.06.2025

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Job Description:

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

Medical Devices Auditor - High Risk Software
UK (with Travel in Europe)

Our EIMEA Medical Devices Auditing Team is always interested in speaking with talented individuals, especially those with experience in High Risk Software.

About you

We seek someone with technical expertise in High Risk Software medical devices, including Research & Design, Validation, Testing or Servicing, combined with experience in Quality Management Systems and understanding of ISO Standards, particularly ISO 13485.

Why join us?

Our Medical Devices team ensures patient safety and supports timely market access for medical device products globally. BSI is a Notified Body with over a century of experience, committed to integrity, respect, and expertise, and to inspiring trust.

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

Benefits in the UK include:

• 27 days of annual leave
• Paid sick leave
• Bank holidays
• Health and 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
• Flexible benefits tailored to your lifestyle

Do you believe the world deserves excellence?

We are proud to help organizations become more sustainable and resilient, inspiring trust in their products, systems, and services.

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

We are committed to diversity and inclusion. If you require accommodations during our recruitment process due to a disability or impairment, please inform your Talent Acquisition Partner.

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

We conduct face-to-face interviews where appropriate. If invited to an in-person interview but prefer to do it virtually, please discuss this with our recruitment team.