Medical Devices Auditor - QMS

BSI Companies; Prato; In loco; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

Join BSI as a Medical Devices Auditor, playing a key role in assessing compliance and quality in medical device organizations. With a focus on ISO standards and a commitment to excellence, you'll help ensure patient safety across the EMEA region. This field-based position involves significant travel, providing rewarding engagement with diverse clients and projects.

Competenze

• At least 4 years of experience in the medical device field.
• Experience with quality management systems.

Mansioni

• Conduct audits for medical devices and quality management systems.
• Prepare reports and manage client schedules.

Conoscenze

Quality Management Systems

Auditing

Regulatory Compliance

Formazione

Bachelor's or higher degree in STEM fields

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’re 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 assist with conformity assessments related to UKCA and CE marking.

Responsibilities:

During the first six months as a Client Manager, you will:

• Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR (Medical Device Regulation)
• Initially observe audit procedures, then progress to conducting audits independently

Post-training, a typical week includes:

• Conducting site, remote, or hybrid audits alone or in teams
• Preparing reports and coordinating with the planning team and delivery manager to manage clients and schedules
• Completing administrative tasks as needed

Minimum requirements include:

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

Experience with a range of medical devices such as:

• IVD (in vitro diagnostics) instrumentation and reagents
• Active implantable devices like cochlear implants, MEMS systems, infusion pumps, including Software as a Medical Device
• Orthopedics, wound and skin care products

Additional requirements:

• At least 2 years of experience working with quality management systems
• University or technical degree in a STEM field (BSc, MSc, PhD) such as Biology, Microbiology, Chemistry, Bioengineering, Medicine, 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 worldwide. If you're eager to contribute to this inspiring mission, bring your enthusiasm to our team, apply now, and join the BSI family!

D&I Policy: BSI values workforce diversity, reflecting our clients and communities. We aim to foster a sense of belonging, providing opportunities for growth, development, and engagement, all while enjoying meaningful work.

LI-DNI

Our Excellence Behaviors: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a positive work environment and business success.

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

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