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!

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

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

We are seeking talented individuals to join our medical device auditor team. The role involves traveling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits include standards like ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support conformity assessment activities related to UKCA and CE marking.

Responsibilities:

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

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

Once fully trained, typically after six months, your weekly activities will include:

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

Minimum requirements for success:

1. At least 4 years of hands-on experience in areas such as:

• Research and development
• Servicing, maintenance, testing
• Manufacturing or production

2) Experience with a range of medical devices, including:

• IVD instrumentation and reagents
• Active Implantable Medical Devices like Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device
• Orthopaedics: spinal implants, cements, cartilage, tissue repair
• Wound and skin care products

3) At least 2 years' experience working with quality management systems

4) A university or technical degree in a STEM field (BSc, MSc, PhD), such as Biology, Microbiology, Chemistry, Biochemistry, Computer Science, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics

Join us in making a difference!

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're eager to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family!

Our Diversity & Inclusion Policy:

We are committed to reflecting the diversity of our clients and communities, fostering a sense of belonging, and providing growth opportunities for all employees. BSI is a community where everyone can thrive.

Additional info:

We conduct face-to-face interviews when appropriate. If invited for an interview but prefer virtual, please inform our recruitment team.

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