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! /ppbPosition: /b Auditor Medical Devices (also known as Client Manager) /ppuLocation: /u Italy - Field-based, with 70%-75% travel within EMEA /ppWe are seeking talented individuals to join our medical device auditing 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 assessments related to UKCA and CE marking. /ppbResponsibilities: /b /ppDuring the first six months as a Client Manager, you will: /pulliReceive training in ISO 13485 Lead Auditor, MDSAP, and MDR (Medical Device Regulation) /liliInitially observe audit procedures, then conduct audits independently /li /ulpbPost-training, your typical weekly activities include: /b /pulliConducting on-site, remote, or hybrid audits alone or in teams /liliPreparing reports and coordinating with planning and delivery teams to manage clients and schedules /liliPerforming administrative tasks as needed /li /ulpbCandidate Requirements: /b /polliMinimum of 4 years’ hands-on experience in areas such as research and development, servicing, maintenance/testing, or manufacturing/production /liliExperience covering medical devices such as: /li /olulliIVD (in vitro diagnostics) instrumentation and reagents /liliActive Implantable Medical Devices like Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device /liliOrthopaedics—spinal implants, cements, cartilage, soft tissue repair /liliWound and skin care—dressings, foams, gels /li /ulliAt least 2 years’ experience working with quality management systems /liliDegree in a STEM field (BSc, MSc, or PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics /lipDo you believe the world deserves excellence? /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 want to contribute to this inspiring mission, bring your enthusiasm to our team, apply now, and join the BSI family! /ppbDI Policy: /b BSI is committed to workforce diversity, reflecting our clients and communities. We aim to create an inclusive environment where everyone can thrive, grow, and engage with our global organization while enjoying their work. /ppbLI-DNI /b /ppOur core behaviors: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a positive workplace and business success. /ppWe conduct face-to-face interviews where feasible. If invited for an in-person interview but prefer virtual, please discuss this with our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr