Medical Devices Auditor - QMS

BSI Companies; Biella; Ibrido; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

Join BSI Companies as a Medical Devices Auditor, where you will assess quality management systems across various EMEA sites. This critical role involves ensuring regulatory compliance for medical devices through rigorous audits. With a strong emphasis on patient safety and quality assurance, you will play a vital part in supporting healthcare innovation.

Servizi

Opportunities for professional growth

Dynamic and inclusive work environment

Travel opportunities across EMEA

Competenze

• At least 4 years of hands-on experience in related fields.
• Minimum 2 years' experience with QMS.
• Degree in Biology, Chemistry, or related STEM fields.

Mansioni

• Conduct audits on-site or remotely after training.
• Prepare reports and manage client schedules.
• Perform administrative tasks as needed.

Conoscenze

Quality Management Systems

ISO 9001

ISO 13485

Medical Devices Compliance

Formazione

University or technical degree in a STEM field

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!

Position: 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 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 assist with conformity assessments related to UKCA and CE marking.

Responsibilities:

Initial six months:

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

Post-training weekly activities:

• Conduct audits on-site, remotely, or in hybrid formats, independently or as part of a team
• Prepare reports and coordinate with planning and management teams to oversee clients and schedules
• Perform administrative tasks as needed

Minimum experience required:

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

Experience with medical devices:

• Active devices (e.g., X-rays, Heart Lung machines, Defibrillators, MRI Scanners)
• IVD (in vitro diagnostics) instrumentation and reagents
• Active Implantable Medical Devices (e.g., Cochlear Implants, MEMS, infusion pumps)
• Orthopaedics (spinal implants, bone/dental cements, cartilage, soft tissue repair)
• Wound and skin care products (dressings, foams, gels)

Additional requirements:

• Minimum 2 years' experience working with quality management systems
• University or technical degree in a STEM field (BSc, MSc, PhD) such as Biology, Chemistry, Computer Science, Electrical, Mechanical, Bioengineering, 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 globally. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team. Apply now and join the BSI family!

Diversity & Inclusion Policy:

BSI values workforce diversity and aims to create an inclusive environment that reflects our communities. We offer opportunities for growth, development, and engagement, fostering a sense of belonging for all employees.

Our Behaviors: Client-centric, Agile, Collaborative. These guide how we operate and ensure BSI is a great place to work and a successful business.

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

J-18808-Ljbffr