Medical Devices Auditor - QMS

Medical Devices Auditor - QMS

Apply locations: Italy | Posted on: 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

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 such as ISO 9001 / ISO 13485 and schemes like MDSAP. We also support conformity assessment activities related to UKCA and CE marking.

Responsibilities:

Initially, as a new Client Manager, you will:

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

Once fully trained, typical weekly activities include:

• Conducting audits onsite, remotely, or in a hybrid manner, alone or as part of a team
• Writing reports and coordinating with planning and delivery teams to manage clients and schedules
• Performing administrative duties as needed

Minimum requirements:

1. At least 4 years of hands-on experience in research and development, servicing, maintenance/testing, or manufacturing/production
2. Experience with a range of medical devices, including:

• IVD (in vitro diagnostics) reagents and instrumentation
• Active implantable devices like cochlear implants, MEMS, infusion pumps, including Software as a Medical Device
• Orthopedic devices such as spinal implants, cements, cartilage, soft tissue repair
• Wound and skin care products like dressings, gels, foams

Additionally,:

1. You should have at least 2 years' experience working with quality management systems
2. You must possess a university or technical degree (BSc, MSc, PhD) in a related STEM field such as Biology, Microbiology, Chemistry, 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 86,000 companies across 193 countries. If you want to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family!

Our Commitment: BSI is dedicated to workforce diversity and creating an inclusive environment where everyone can thrive. We aim to reflect our community's diversity and provide opportunities for growth and engagement.

Additional Information: We conduct face-to-face interviews where feasible. If invited to an in-person interview but prefer virtual, please discuss this with our recruitment team.

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