Medical Devices Auditor - QMS

Medical Devices Auditor - QMS

Apply locations: Italy | Posted: 30+ Days Ago | Job requisition id: JR0016196

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

Location: Italy - field-based, 70%-75% travel within EMEA required

We are seeking talented individuals to join our medical device auditor team. The role involves traveling to various sites 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, as well as conformity activities related to UKCA and CE marking.

Responsibilities:

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

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

Post-training, your weekly activities will typically include:

• Conducting audits onsite, remotely, or in hybrid formats, alone or in teams
• Writing reports and coordinating with planning and delivery teams to manage clients and schedules
• Performing administrative tasks as needed

Minimum requirements:

• At least 4 years of hands-on experience in areas such as research and development, design, servicing, maintenance, testing, manufacturing, or production

Additional experience:

• Experience with a range of medical devices including:
• Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
• IVD (in vitro diagnostics): instrumentation and reagents
• Active Implantable Devices: Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device
• Orthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repair
• Wound and skin care: dressings, foams, gels

Qualifications:

• At least 2 years' experience with quality management systems
• University or technical degree in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics

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 worldwide. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family!

D&I Policy: BSI values workforce diversity to reflect our clients and communities. We aim to create a sense of belonging, offering opportunities for growth and engagement within our global organization.

Our Behaviors: Client-centric, Agile, Collaborative — guiding how we operate at BSI.

We conduct face-to-face interviews where possible. If invited for an in-person interview but prefer virtual, please discuss with our recruitment team.

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