Medical Devices Auditor - QMS

TN United Kingdom; West of England; On-site; GBP 40,000 - 70,000; Full time

Job summary

Join a forward-thinking organization dedicated to patient safety and market access for medical devices. This role offers the opportunity to work with High Risk Software medical devices, ensuring compliance with Quality Management Systems and ISO standards. You will be part of a team that values integrity and expertise, providing you with structured training and career development. With a commitment to diversity and inclusion, this position is ideal for professionals looking to make a significant impact in the medical field while enjoying competitive benefits and a supportive work environment.

Benefits

27 days annual leave

Paid sick leave

Health and life insurance

Pension plan with company contributions

Car allowance

Income protection

Paid parental leave

Learning and development opportunities

Flexible benefits

Qualifications

• Experience in High Risk Software medical devices is essential.
• Knowledge of ISO 13485 and Quality Management Systems is required.

Responsibilities

• Ensure compliance with ISO standards and Quality Management Systems.
• Conduct audits for medical devices to ensure patient safety.

Skills

High Risk Software medical devices

Quality Management Systems

ISO standards

Research and design

Validation and testing

Servicing of medical devices

Job description

Job Title: Medical Devices Auditor - QMS, South Gloucestershire

Join BSI's EIMEA Medical Devices Auditing Team, where we focus on ensuring patient safety and supporting market access for medical devices globally. We are seeking talented individuals with experience in High Risk Software medical devices, including research, design, validation, testing, or servicing, combined with knowledge of Quality Management Systems and ISO standards, especially ISO 13485.

About the Role

This position is based in the UK with travel across Europe. We welcome applications from candidates outside the UK in European countries.

Candidate Profile

We are looking for professionals with expertise in High Risk Software medical devices, and a background in Quality Management Systems and ISO standards. Experience in research, design, validation, testing, or servicing of medical devices is essential.

Why Join Us?

At BSI, we prioritize patient safety and support our clients' market access. With over a century of experience, we uphold values of integrity, respect, and expertise. We offer structured induction, comprehensive training, and tailored career development paths.

Benefits in the UK

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

About BSI

Headquartered in London, BSI is the world's first national standards organization, serving over 86,000 companies in more than 193 countries. We provide development, auditing, certification, and training services across various industries, including aerospace, automotive, food, healthcare, and more. As a Royal Charter company, we are impartial and home to the Kitemark.

Our Commitment

We value diversity and aim to create an inclusive environment where everyone can thrive. We are committed to providing reasonable accommodations for candidates with disabilities during the recruitment process. Our behaviors include being client-centric, agile, and collaborative.

Interview Process

We conduct face-to-face interviews when appropriate, but virtual interviews are available upon request for your comfort.