QMS Medical Devices Auditor - High Risk Software

TN United Kingdom; Birmingham; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a skilled Medical Devices Auditor specializing in High Risk Software. This role involves ensuring compliance with stringent ISO standards and quality management systems while contributing to patient safety and timely market access. The position offers a structured induction and training program, alongside a flexible benefits package, including generous annual leave and health insurance. Join a diverse and inclusive environment where your expertise will inspire trust and drive sustainable practices in medical device auditing across Europe.

Benefits

27 days of annual leave

Paid sick leave

Health and life insurance

Pension plan with company contribution

Car allowance

Flexible benefits

Learning and development opportunities

Paid parental leave

Compassionate leave

Bereavement leave

Qualifications

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

Responsibilities

• Conduct audits for High Risk Software medical devices.
• Ensure compliance with ISO standards and quality management.

Skills

High Risk Software

Quality Management Systems

ISO 13485

Research & Design

Validation

Testing

Servicing

Job description

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QMS Medical Devices Auditor - High Risk Software, Birmingham

Client: BSI

Location: Birmingham, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference:

a6f1ab6e9c50

Job Views:

7

Posted:

26.04.2025

Expiry Date:

10.06.2025

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 interested in 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, and experience with Quality Management Systems and ISO Standards, particularly ISO 13485.

Why should you join us?

Our Medical Devices team ensures patient safety and supports timely market access globally. BSI, a Notified Body with over a century of experience, values integrity, respect, expertise, and inspires trust.

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

Benefits in the UK:

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 parental leave, adoption leave, compassionate leave, bereavement leave, learning and development opportunities, and flexible benefits.

Our Mission:

We aim to make the world more sustainable and resilient, inspiring trust through our work.

Headquartered in London, BSI is the world's first national standards organization, serving over 86,000 companies in 193 countries with certification, training, and consulting services, including cybersecurity and software solutions.

We foster a diverse and inclusive environment where everyone can thrive. If you need accommodations during the recruitment process, please inform your Talent Acquisition Partner.

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Our Excellence Behaviours: Client-centric, Agile, Collaborative. We conduct face-to-face interviews where appropriate, but virtual options are available upon request.