Medical Devices Auditor - QMS

BSI Companies; Latina; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

BSI is seeking a Medical Devices Auditor to join their team, involving travel throughout EMEA to assess quality management systems. The candidate will conduct various types of audits in line with international standards while supporting patient safety and regulatory compliance. Required qualifications include substantial experience in relevant fields and a degree in a STEM discipline, alongside outstanding auditing and organizational skills.

Competenze

• At least 4 years of experience in relevant fields.
• Experience with a range of medical devices.
• Minimum 2 years working with quality management systems.

Mansioni

• Conduct on-site, remote, or hybrid audits.
• Write reports and coordinate audits.
• Perform administrative duties as needed.

Conoscenze

Quality management systems

ISO 9001

ISO 13485

MDSAP

Regulatory compliance

Formazione

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

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 like ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support 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 tasks:

• Conduct on-site, remote, or hybrid audits alone or in teams
• Write reports and coordinate with planning and delivery teams
• Perform administrative duties as needed

Minimum Requirements:

1. At least 4 years of experience in research and development, servicing, maintenance/testing, or manufacturing
2. Experience with a range of medical devices including IVD, active implantables, orthopaedics, or wound care
3. Minimum 2 years working with quality management systems
4. Degree in a STEM field such as Biology, Microbiology, Chemistry, Software Technology, Engineering, 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 across 193 countries. If you are inspired by this mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family!

Our Commitment:

BSI values diversity and aims to create a sense of belonging for all employees, offering opportunities to develop, grow, and engage globally while enjoying the work. We are a community where everyone can thrive.

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

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