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 required 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 include 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 Observe audit procedures and progress to conducting audits independently Post-training, your typical weekly activities include: Conducting on-site, remote, or hybrid audits solo or in teams Writing reports and coordinating with planning and delivery teams to manage clients and schedules Performing administrative tasks as needed Minimum requirements: At least 4 years of hands-on experience in areas such as research and development, design, servicing, maintenance, testing, manufacturing, or production Experience with medical devices: Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners IVD instrumentation and reagents Active Implantable Devices: Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device Orthopaedics: spinal implants, cements, cartilage, tissue repair Wound and skin care products Additional qualifications: Minimum 2 years' experience with quality management systems University or technical degree in a STEM field (BSc, MSc, PhD) such as Biology, Chemistry, Computer Science, Electrical, Mechanical, Bioengineering, 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 globally. If you are eager to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family! Diversity & Inclusion Policy: BSI values workforce diversity and aims to create an inclusive environment where everyone can thrive. We support opportunities for development, growth, and engagement across our global organization. Additional Information: We conduct face-to-face interviews where appropriate. If invited for an interview but prefer virtual, please discuss with our recruitment team. J-18808-Ljbffr J-18808-Ljbffr