Medical Devices Auditor - QMS

BSI Companies; Piemonte; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

BSI Companies is seeking a Medical Devices Auditor to join their team. This field-based role involves assessing quality management systems while traveling approximately 70-75% of the time. Candidates should have a technical degree and relevant experience in the medical device industry. The role will entail various auditing tasks post-training, contributing to regulatory compliance and patient safety.

Competenze

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

Mansioni

• Conduct audits onsite, remotely, or hybrid.
• Write reports and manage clients and schedules.
• Receive training in ISO 13485 Lead Auditor.

Conoscenze

Experience in quality management systems

Knowledge of ISO 9001 / ISO 13485

Client management

Knowledge of medical devices standards

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!

Role: 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 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:

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

Once fully trained, your weekly activities will include:

• Conducting audits onsite, remotely, or in hybrid formats, alone or in teams
• Writing reports and coordinating with planning and delivery teams to manage clients and schedules
• Performing administrative tasks as needed

Minimum requirements:

1. At least 4 years of hands-on experience in areas such as research and development, servicing, maintenance/testing, or manufacturing
2. Experience with a range of medical devices, including IVDs, active implantables, orthopedics, and wound care products
3. Minimum 2 years working with quality management systems
4. University or technical degree in a STEM field (BSc, MSc, PhD), such as Biology, Chemistry, Computer Science, Electrical, Mechanical, Bioengineering, Medicine, Pharmacy, Physics, etc.

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 across 193 countries. If you’re eager to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family!

Diversity & Inclusion Policy:

BSI values workforce diversity to reflect our clients and communities. We aim to create an inclusive environment where everyone can thrive and grow while enjoying their work.

Our Excellence Behaviors: Client-centric, Agile, Collaborative. These guide how we operate and ensure BSI remains a great place to work and succeed.

We conduct face-to-face interviews where appropriate. If invited but more comfortable virtually, please discuss this with our recruitment team.

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