Medical Devices Auditor - QMS

BSI Companies; Lecce; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading company in the medical device sector is seeking a Medical Devices Auditor to join their team. This field-based role requires substantial travel within EMEA and focuses on auditing quality management systems. Ideal candidates will have a strong background in medical devices and quality assurance, with a commitment to patient safety and regulatory compliance.

Competenze

• At least 4 years of hands-on experience in medical device development or related fields.
• Minimum 2 years of experience working with quality management systems.

Mansioni

• Conduct site, remote, or hybrid audits independently or as part of a team.
• Write reports and coordinate with planning and delivery teams.

Conoscenze

Quality Management Systems

Auditing

Regulatory Compliance

Patient Safety

Formazione

University degree in 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 locations 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, as well as conformity assessment 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
• Initially observe audits, then conduct them independently

After full training, your weekly activities will include:

• Conducting site, remote, or hybrid audits, independently or as part of a team
• Writing reports and coordinating with planning and delivery teams to manage clients and schedules
• Completing administrative tasks as needed

Minimum qualifications include:

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

Experience with medical devices may include:

• IVD instrumentation and reagents
• Active implantable devices such as cochlear implants, MEMS systems, infusion pumps (including software as a medical device)
• Orthopaedics: spinal implants, cements, cartilage, tissue repair
• Wound and skin care products

Additionally, at least 2 years of experience working with quality management systems is required.

You must have completed a university or technical college degree in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer Science, Electrical, Electronic, Mechanical Engineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics.

Join us in our mission to deliver 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're enthusiastic about contributing to this mission, apply now and become part of the BSI family!

Diversity & Inclusion Policy:

BSI values workforce diversity and aims to reflect the communities we serve. We strive to create an inclusive environment where everyone can thrive, grow, and engage with our global organization.

Additional Information:

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

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