Medical Devices Auditor - QMS

BSI Group; Pistoia; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading company in standards organization is seeking a Medical Devices Auditor to join their quality management team. This role involves significant travel within EMEA and requires expertise in auditing, regulatory compliance, and quality systems. Ideal candidates will hold a degree in a STEM field and have considerable experience in the medical device industry. The position offers the opportunity to support patient safety and ensure compliance with important industry standards.

Competenze

• At least 4 years of hands-on experience in related fields.
• Experience with medical devices like IVD, active implantable devices, and wound care products.
• At least 2 years working with quality management systems.

Mansioni

• Conduct audits on-site, remotely, or in hybrid formats.
• Prepare reports and coordinate with planning and delivery teams.
• Receive training on ISO 13485 Lead Auditor, MDSAP, and MDR.

Conoscenze

Quality Management Systems

ISO 9001

ISO 13485

MDSAP

Regulatory Compliance

Formazione

Degree in STEM field (BSc, MSc, or PhD)

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

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. We also support conformity assessments related to UKCA and CE marking.

Responsibilities:

First six months:

• Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR.
• Initially observe audits, then conduct them independently.

Post-training weekly activities:

• Conduct audits on-site, remotely, or in hybrid formats, individually or as part of a team.
• Write reports and coordinate with planning and delivery teams to manage clients and schedules.
• Perform administrative tasks as needed.

Minimum requirements:

• At least 4 years of hands-on experience in research and development, servicing, maintenance/testing, or manufacturing/production.
• Experience with a range of medical devices, including IVD, active implantable devices, orthopaedics, and wound care products.
• At least 2 years of experience working with quality management systems.
• Degree in a STEM field (BSc, MSc, or PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, 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 in over 193 countries. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team. Apply now and join the BSI family!

D&I Policy: BSI is committed to workforce diversity, reflecting our clients and communities. We aim to create an inclusive environment where everyone can thrive and grow.

Additional Information: Our behaviors include Client-centric, Agile, and Collaborative. We conduct face-to-face interviews where appropriate, but virtual options are available upon request.

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