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 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 such as ISO 9001 / ISO 13485 and schemes like MDSAP. We also support conformity assessments related to UKCA and CE marking. /ppbResponsibilities: /b /ppbIn the first six months as a Client Manager, you will: /b /pulliReceive training in ISO 13485 Lead Auditor, MDSAP, and MDR /liliObserve audit procedures and progress to conducting audits independently /li /ulpbPost-training, your typical weekly activities include: /b /pulliConducting on-site, remote, or hybrid audits solo or in teams /liliWriting reports and coordinating with planning and delivery teams to manage clients and schedules /liliPerforming administrative tasks as needed /li /ulpbMinimum requirements: /b /pulliAt least 4 years of hands-on experience in areas such as research and 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, cements, cartilage, tissue repair /liliWound and skin care products /li /ulpbAdditional qualifications: /b /pulliMinimum 2 years' experience with quality management systems /liliUniversity or technical degree in a STEM field (BSc, MSc, PhD) such as Biology, Chemistry, Computer Science, Electrical, Mechanical, Bioengineering, 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 over 86,000 companies globally. If you are eager 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 values workforce diversity and aims to create an inclusive environment where everyone can thrive. We support opportunities for development, growth, and engagement across our global organization. /ppbAdditional Information: /b /ppWe conduct face-to-face interviews where appropriate. If invited for an interview but prefer virtual, please discuss with our recruitment team. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr