Medical Devices Auditor - QMS

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

Job summary

An established industry player is seeking a Medical Devices Auditor to join their team in Loughborough. This role offers a unique opportunity to work with high-risk software medical devices, ensuring compliance with ISO13485 and other quality management standards. The position involves travel across Europe, providing a dynamic work environment. The company is committed to patient safety and offers comprehensive training and career development. Join a forward-thinking organization that values integrity, respect, and expertise, and make a tangible impact in the medical devices sector.

Benefits

27 days of annual leave

Paid sick leave and holidays

Health and life insurance

Pension plan with company contribution

Car allowance

Income protection

Parental leave

Flexible benefits

Qualifications

• Experience with High Risk Software medical devices is essential.
• Knowledge of Quality Management Systems and ISO Standards is crucial.

Responsibilities

• Conduct audits for medical devices ensuring compliance with ISO standards.
• Travel across Europe for auditing and training purposes.

Skills

High Risk Software

Quality Management Systems

ISO13485

Research & Design

Validation

Testing

Servicing

Job description

Medical Devices Auditor - QMS, Loughborough

Join BSI as a Medical Devices Auditor based in Loughborough, UK, with travel across Europe. We are open to applications from candidates outside the UK residing in European countries.

About the Role

Our EIMEA Medical Devices Auditing Team is seeking talented professionals, especially those experienced with High Risk Software medical devices. We value expertise in Research & Design, Validation, Testing, or Servicing combined with knowledge of Quality Management Systems and ISO Standards, particularly ISO13485.

Why Join Us?

BSI ensures patient safety and supports market access for medical device products globally. We uphold values of integrity, respect, and expertise, aiming to inspire trust. We offer structured induction, comprehensive training, and tailored career development paths.

Benefits in the UK

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

About BSI

Headquartered in London, BSI is the world's first national standards organization with over 100 years of experience. We serve over 86,000 organizations across 193 countries, providing certification, training, and innovative solutions in various industries. We are committed to diversity and inclusion, fostering a community where everyone can thrive.

Application Process

If you are passionate about making a difference and meet the role requirements, apply now to join our dynamic team. We conduct face-to-face or virtual interviews based on circumstances.