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 auditor team. The role requires 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 assessment activities 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 /liliInitially observe audits, then conduct them independently /li /ulpbAfter full training, your weekly tasks will include: /b /pulliConducting audits onsite, remotely, or in hybrid mode, independently or in teams /liliWriting reports and coordinating with planning and delivery teams to manage clients and schedules /liliPerforming administrative duties as needed /li /ulpbMinimum qualifications include: /b /pulliAt least 4 years of hands-on experience in research and development, servicing, maintenance/testing, or manufacturing/production /li /ulpbExperience with a range of medical devices such as: /b /pulliIVD (in vitro diagnostics) instrumentation/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 products: dressings, foams, gels /li /ulpAdditionally, at least 2 years of experience working with quality management systems is required. /ppYou should have completed a university or technical college degree (BSc, MSc, or PhD) in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical/Electronic/Mechanical/Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics. /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 and organizations in more than 193 countries. If you're eager to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family! /ppbDI Policy: /b /ppBSI is committed to workforce diversity, reflecting the communities we serve. We aim to create an inclusive environment where everyone can thrive, develop, and engage 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 appropriate. If invited for an in-person interview but prefer virtual, please discuss this with our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr