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 (internally known as Client Manager) /ppuLocation: /u Italy - field-based, 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 cover standards like ISO 9001 / ISO 13485 and schemes such as MDSAP, as well as conformity assessments related to UKCA and CE marking. /ppbResponsibilities: /b /ppbInitial Six Months: /b /pulliReceive training in ISO 13485 Lead Auditor, MDSAP, and MDR /liliObserve audit procedures and gradually conduct audits independently /li /ulpbAfter Full Training (Typical Week): /b /pulliConduct on-site, remote, or hybrid audits independently or with a team /liliPrepare reports and coordinate with planning and delivery teams to manage clients and schedules /liliPerform administrative tasks as needed /li /ulpbQualifications: /b /pulliMinimum of 4 years' experience in research development, design, servicing, maintenance, testing, manufacturing, or production /li /ulpbExperience with Medical Devices: /b /pulliActive devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners /liliIVD instrumentation and reagents /liliActive Implantable Devices: Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device /liliOrthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repair /liliWound and skin care products /li /ululliAt least 2 years' experience with quality management systems /li /ululliDegree in STEM field (BSc, MSc, PhD): Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics /li /ulpDo 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 86,000 companies in over 193 countries. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family! /ppbDiversity Inclusion Policy: /b /ppBSI is committed to workforce diversity, reflecting our clients and communities. We aim to create a sense of belonging by providing growth opportunities and engaging with our global organization while having fun. Everyone can thrive here. /ppbLI-DNI /b /ppOur Excellence Behaviors: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a great workplace and successful business. /ppWe conduct face-to-face interviews where appropriate. If invited for an in-person interview but prefer virtual, please discuss with our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr