Medical Devices Auditor - QMS

BSI Companies; Vercelli; Remoto; EUR 45.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company in the field of medical devices is seeking a Medical Devices Auditor to ensure quality management systems align with regulations like ISO 13485. The role offers opportunities for travel across EMEA and involves comprehensive auditing responsibilities, making a significant impact on patient safety and regulatory compliance.

Competenze

• At least 4 years of experience in the medical device field.
• Experience with ISO 13485 and quality management systems.
• University degree in Biology, Microbiology, Chemistry, or related fields.

Mansioni

• Conducting inspections and audits for client quality systems.
• Writing detailed reports and coordinating with teams.
• Traveling frequently (70%-75% of the time) for onsite audits.

Conoscenze

Quality Management Systems

Medical Device Regulations

ISO 13485

Auditing

Formazione

University or Technical College Degree in a related 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 assessment activities 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 audits and then conduct them independently

Once fully trained, a typical week includes:

• Conducting audits onsite, remotely, or in a hybrid manner, alone or with a team
• Writing reports and coordinating with the planning team and delivery manager regarding clients and schedules
• Performing administrative tasks as needed

Minimum requirements include:

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

Experience with medical devices such as:

• Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
• IVD (in vitro diagnostics) instrumentation and reagents
• Active Implantable Medical Devices: Cochlear Implants, MEMS systems, infusion pumps (including Software as a Medical Device)
• Orthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repair
• Wound and skin care: dressings, foams, gels

Additionally, you should have at least 2 years' experience working with quality management systems and hold a university or technical college degree (BSc, MSc, or PhD) in a related STEM field 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 are a global partner to 86,000 companies and organizations in over 193 countries. If you want to contribute to this inspiring mission, bring your open and enthusiastic mindset to our dynamic team, apply now, and become part of the BSI family!

D&I Policy:

BSI is committed to workforce diversity, reflecting our clients and communities. We aim to create a sense of belonging by providing opportunities for development, growth, and engagement within our global organization, all while having fun doing great work. BSI is a community where everyone can thrive.

LI-DNI

Our core behaviors: Client-centric, Agile, Collaborative. These behaviors guide how we operate at BSI, ensuring a great workplace and business success.

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

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