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 such as ISO 9001 / ISO 13485 and schemes like MDSAP. We also support conformity assessments related to UKCA and CE marking. /ppbResponsibilities: /b /ppIn the first six months as a Client Manager, you will: /pulliReceive training in ISO 13485 Lead Auditor, MDSAP, and MDR /liliObserve audit procedures and then conduct audits independently /li /ulpbPost-training, your weekly activities will typically include: /b /pulliConducting on-site, remote, or hybrid audits alone or with a team /liliWriting reports and coordinating with the planning team and delivery manager /liliCompleting administrative tasks as needed /li /ulpbMinimum requirements: /b /ppMinimum 4 years of hands-on experience in areas such as: /pulliResearch and development /liliDesign or design development /liliServicing, maintenance, or testing /liliManufacturing or production /li /ulpExperience with a range of medical devices including: /pulliActive devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners /liliIVD (in vitro diagnostics): instrumentation and reagents /liliActive Implantable Devices: Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device /liliOrthopaedics: spinal implants, cements, cartilage, tissue repair /liliWound and skin care: dressings, foams, gels /li /ulpAt least 2 years' experience working with quality management systems. /ppEducational qualifications in STEM fields (BSc, MSc, PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics are required. /ppbDo you believe the world deserves excellence? /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 globally. If you want to contribute to this mission, bring your enthusiasm to our team, apply now, and join the BSI family! /ppbDI Policy: /b /ppWe are committed to workforce diversity, reflecting our communities and clients. We aim to foster a sense of belonging and provide growth opportunities for all employees. BSI is a community where everyone can thrive. /ppbLI-DNI /b /ppOur core Behaviors: Client-centric, Agile, Collaborative. These guide how we operate and ensure BSI remains a great place to work and succeed. /ppWe conduct face-to-face interviews where appropriate. If invited but preferring virtual interviews, please discuss with our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr