Medical Devices Auditor - QMS

TN United Kingdom; City of Edinburgh; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Medical Devices Auditor to join their dynamic team in Edinburgh. This role involves ensuring compliance with high standards for medical devices, particularly in areas like Research & Design, Validation, and Testing. The company prides itself on its commitment to patient safety and offers a supportive environment with comprehensive training and development opportunities. With a rich history and a focus on integrity, this position is perfect for those passionate about making a difference in the medical field. Join a team that values collaboration and innovation, and help shape the future of medical device auditing.

Benefits

27 days annual leave

Paid sick leave

Health and life insurance

Pension plan with company contribution

Car allowance

Income protection

Paid parental leave

Learning and development opportunities

Flexible benefits

Qualifications

• Experience with High Risk Software medical devices is essential.
• Understanding of ISO Standards, particularly ISO13485, is required.

Responsibilities

• Conduct audits of medical devices to ensure compliance with regulations.
• Support timely market access for medical device products globally.

Skills

High Risk Software

Quality Management Systems

ISO13485

Research & Design

Validation

Testing

Servicing

Job description

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Medical Devices Auditor - QMS, Edinburgh

Client: BSI

Location: Edinburgh, United Kingdom

Job Category: -

EU work permit required: Yes

Job Reference: 2a611f80cccc

Job Views: 11

Posted: 29.04.2025

Expiry Date: 13.06.2025

Job Description:

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

We are seeking a Medical Devices Auditor based in UK with Travel in Europe. We welcome applications from candidates outside the UK as well.

Our EIMEA Medical Devices Auditing Team values talented individuals, especially those experienced with High Risk Software medical devices, including Research & Design, Validation, Testing, or Servicing. Experience with Quality Management Systems and understanding of ISO Standards, particularly ISO13485, is essential.

Why join us?

Our Medical Devices team ensures patient safety and supports timely market access for medical device products globally. BSI, with over a century of history as a Notified Body, continues to grow while upholding values of integrity, respect, and expertise. We foster a culture of trust and provide structured induction, full training programs, and tailored learning paths.

Benefits in the UK include:

• 27 days annual leave
• Paid sick leave, bank holidays
• Health and life insurance
• Pension plan with company contribution
• Car allowance (role dependent)
• Income protection
• Paid parental and compassionate leave
• Learning and development opportunities
• Flexible benefits tailored to your lifestyle

Our mission: To be the business improvement partner that helps organizations become more sustainable, resilient, and trustworthy in their products and services.

Headquartered in London, BSI is the world's first national standards organization, serving over 86,000 companies in 193+ countries with a variety of services including certification, auditing, training, and innovative software solutions.

If you’re passionate about making a difference and eager to join a dynamic team, apply now and become part of the BSI family!

D&I Policy: BSI is committed to diversity and inclusion, providing equal opportunities and accommodations for all employees and applicants.

We value client-centric, agile, and collaborative behaviors, ensuring BSI remains a great place to work and a successful business. Face-to-face interviews are conducted where appropriate, with options for virtual interviews upon request.