Medical Devices Auditor - QMS

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

Descrizione del lavoro

A leading company in the medical devices field seeks a Medical Devices Auditor to join their team. This role entails conducting audits across various locations, ensuring compliance with regulatory standards, and supporting safety in patient care. The position demands significant travel within the EMEA region and offers a chance to be part of a respected global organization committed to quality and excellence in the field.

Competenze

• At least 4 years of experience in medical devices or related sectors.
• Experience with active and implantable medical devices.
• At least 2 years' experience with quality management systems.

Mansioni

• Conduct onsite and remote audits, alone or in teams.
• Write reports and coordinate with planning teams.
• Complete administrative tasks as required.

Conoscenze

Quality Management Systems

Auditing

Regulatory Compliance

Formazione

BSc, MSc, or PhD 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!

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 assessment activities 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 (Medical Device Regulation)
• Initially observe audit processes, then progress to conducting audits independently

Post-training, your weekly activities will typically include:

• Conducting audits onsite, remotely, or in a hybrid manner, either alone or as part of a team
• Writing reports and coordinating with the planning team and delivery manager to manage clients and schedules
• Completing administrative tasks as required

Minimum requirements:

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

Experience with medical devices:

• Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
• IVD (in vitro diagnostics) instrumentation and reagents
• Active implantable 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 products: dressings, foams, gels

Additional qualifications:

• At least 2 years' experience working with quality management systems
• University or technical college degree (BSc, MSc, or PhD) in a 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 partner with over 86,000 companies worldwide. If you wish to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family!

Diversity & Inclusion Policy:

BSI is committed to reflecting the diversity of our clients and communities. We aim to create a sense of belonging for all employees by providing development opportunities and fostering engagement within our global organization. Everyone can thrive here.

Additional info:

Our core behaviors are Client-centric, Agile, and Collaborative, guiding how we operate at BSI. We conduct face-to-face interviews where appropriate; if you prefer a virtual interview, please inform our recruitment team.

J-18808-Ljbffr