PbMedical Devices Auditor - QMS /b /ppApply locations: Italy | Posted: 30+ Days Ago | Job requisition id: JR0016196 /ppGreat that you're considering a career with BSI! /ppbRole: /b Auditor Medical Devices (also known as Client Manager) /ppuLocation: /u Italy - field-based, with 70%-75% travel within EMEA required /ppWe 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 like ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support conformity assessment activities related to UKCA and CE marking. /ppbResponsibilities: /b /ppInitially, during the first six months, as a Client Manager, you will: /pulliReceive training in ISO 13485 Lead Auditor, MDSAP, and MDR /liliObserve audit procedures and progressively conduct audits independently /li /ulpOnce fully trained, typically after six months, your weekly activities will include: /pulliConducting onsite, remote, or hybrid audits alone or in teams /liliWriting reports and coordinating with planning and delivery teams to manage clients and schedules /liliCompleting administrative tasks as needed /li /ulpbMinimum requirements for success: /b /polliAt least 4 years of hands-on experience in areas such as: /li /olulliResearch and development /liliServicing, maintenance, testing /liliManufacturing or production /li /ulp2) Experience with a range of medical devices, including: /pulliIVD instrumentation and reagents /liliActive Implantable Medical Devices like Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device /liliOrthopaedics: spinal implants, cements, cartilage, tissue repair /liliWound and skin care products /li /ulp3) At least 2 years' experience working with quality management systems /pp4) A university or technical degree in a STEM field (BSc, MSc, PhD), such as Biology, Microbiology, Chemistry, Biochemistry, Computer Science, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics /ppbJoin us in making a difference! /b /ppHeadquartered 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 and apply now to join the BSI family! /ppbOur Diversity Inclusion Policy: /b /ppWe are committed to reflecting the diversity of our clients and communities, fostering a sense of belonging, and providing growth opportunities for all employees. BSI is a community where everyone can thrive. /ppbAdditional info: /b /ppWe conduct face-to-face interviews when appropriate. If invited for an interview but prefer virtual, please inform our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr