Medical Devices Auditor - QMS

Medical Devices Auditor - QMS

Apply locations: Italy | Posted: 30+ days ago | Job Requisition ID: JR0016196

Join BSI and advance your career as a Medical Devices Auditor (Client Manager).

Location: Italy - field-based, with 70%-75% travel within EMEA.

We seek talented individuals to join our medical device audit team. The role involves traveling to various sites 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, along with conformity assessments for UKCA and CE markings.

Responsibilities:

• During the first six months, you will receive training in ISO 13485 Lead Auditor, MDSAP, and MDR.
• Initially observe audits, then conduct them independently as you gain experience.

Post-training, your weekly tasks include:

• Conducting audits on-site, remotely, or in a hybrid manner, independently or as part of a team.
• Preparing reports and coordinating with planning and delivery teams to manage clients and schedules.
• Completing administrative duties as required.

Candidate minimum requirements:

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

Experience with a range of medical devices such as:

• Active devices: X-rays, MRI scanners, defibrillators, heart-lung machines.
• IVD (in-vitro diagnostics) instrumentation and reagents.
• Active implantable devices: cochlear implants, infusion pumps, MEMS systems, including software as a medical device.
• Orthopedic devices: spinal implants, bone/dental cements, cartilage, soft tissue repair.
• Wound and skin care products: dressings, gels, foams.

Additional requirements:

• Minimum 2 years' experience working with quality management systems.
• University or technical degree in a STEM field (BSc, MSc, or PhD), such as Biology, Microbiology, Chemistry, Bioengineering, Medicine, etc.

Do you believe the world deserves excellence? Join BSI, headquartered in London, with over 100 years of experience, serving 86,000 companies globally. Bring your enthusiasm and apply now to be part of our team!

Our Policies and Culture:

• We value diversity and aim to create an inclusive environment where everyone can thrive.
• We promote our core behaviors: Client-centric, Agile, Collaborative.

We conduct face-to-face interviews where possible. If you prefer a virtual interview, discuss this with our recruitment team.

J-18808-Ljbffr