Medical Devices Auditor - QMS

BSI Companies; Palermo; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company in the medical sector seeks an Auditor for Medical Devices. The role involves quality management audits across EMEA with significant travel. Candidates should have a solid background in medical devices and quality assurance, along with a degree in a STEM field. This position offers a great opportunity to contribute to patient safety and regulatory compliance.

Competenze

• 4+ years of hands-on experience in R&D, servicing, maintenance, or testing.
• Experience with a range of medical devices including IVD and active implantable devices.
• 2+ years working with quality management systems.

Mansioni

• Conduct onsite, remote, or hybrid audits independently.
• Write reports and manage clients and schedules.
• Complete administrative tasks as needed.

Conoscenze

Quality Management Systems

Regulatory Compliance

Auditing

ISO Standards

Medical Device Knowledge

Formazione

University or Technical Degree in STEM

Descrizione del lavoro

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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