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. The role involves traveling to assess quality management systems, supporting patient safety and regulatory compliance. Our audits cover standards like ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support conformity assessments related to UKCA and CE marking.

Responsibilities :

During the first six months as a Client Manager, you will :

• Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR
• Initially observe audits, then conduct them independently

Once fully trained, your weekly activities will include :

• Conducting audits onsite, remotely, or hybrid, alone or in teams
• Writing reports and coordinating with planning and delivery teams
• Performing administrative tasks as needed
• At least 4 years of experience in research and development, servicing, maintenance / testing, or manufacturing

Experience with medical devices such as :

• IVD instrumentation / reagents
• Orthopaedics (spinal implants, cements, cartilage)
• Wound and skin care products

Additional requirements :

• At least 2 years working with quality management systems
• Degree in a STEM field (BSc, MSc, PhD) such as Biology, Chemistry, Software Technology, Engineering, Medicine, etc.

Do you believe the world deserves excellence?

Headquartered in London, BSI is the world's first national standards organization with over 100 years of experience. We partner with over 86,000 companies globally. If you’re eager to contribute to this inspiring mission, bring your enthusiasm to our team, apply now, and join the BSI family!

Diversity & Inclusion Policy :

BSI values workforce diversity and aims to create a sense of belonging for all employees, fostering development, growth, and engagement while enjoying meaningful work. We are a community where everyone can thrive.

Additional notes :

We are conducting face-to-face interviews where appropriate. If invited but prefer virtual interviews, please discuss with our recruitment team.

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