Medical Devices Auditor - QMS

Medical Devices Auditor - QMS

Apply locations: Italy | Posted: 30+ Days Ago | Job Requisition ID: JR0016196

Great that you're considering a career with BSI!

Position: Auditor Medical Devices (also known as Client Manager)

Location: Italy - Field-based, with 70%-75% travel within EMEA

Join our medical device auditor team to assess quality management systems, support patient safety, and ensure regulatory compliance. Our audits cover standards like ISO 9001 / ISO 13485 and schemes such as MDSAP, UKCA, and CE marking.

Responsibilities:

Initial Training (first six months):

• Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR
• Observe audit procedures before conducting audits independently

Post-Training (typical week):

• Conduct audits onsite, remotely, or in a hybrid format, independently or with a team
• Prepare reports and coordinate with planning and delivery teams to manage clients and schedules
• Perform administrative tasks as needed

Minimum Requirements:

• At least 4 years of hands-on experience in research and development, design, servicing, maintenance, testing, or manufacturing of medical devices
• Experience with a range of medical devices such as X-ray machines, MRI scanners, IVDs, implantable devices, orthopaedics, and wound care products
• Minimum of 2 years' experience working with quality management systems
• Degree in a STEM field (BSc, MSc, or PhD) such as Biology, Chemistry, Software Technology, Engineering, Medicine, Pharmacy, Physics, or related fields

Join us to contribute to a safer world through quality and compliance in medical devices. Headquartered in London, BSI is a pioneer with over 100 years of experience, partnering with over 86,000 organizations worldwide.

We value diversity and aim to create an inclusive environment where everyone can thrive. Our behaviors include being client-centric, agile, and collaborative.

We conduct face-to-face interviews where possible. If you prefer virtual interviews, please discuss with our recruitment team.

Apply now and become part of the BSI family!