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 sites 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, along with conformity assessments for 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 /ulpbPost-training, your weekly activities will include: /b /pulliConducting audits onsite, remotely, or in hybrid formats, solo or in teams /liliWriting reports and coordinating with planning and delivery teams to manage clients and schedules /liliCompleting 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 (in vitro diagnostics) instruments and reagents /liliActive Implantable Medical 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: dressings, foams, gels /li /ulpAdditional requirements: /pulliMinimum 2 years' experience with quality management systems /liliUniversity or technical degree in a STEM field (BSc, MSc, PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics /li /ulpbJoin us in our mission to deliver 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 across 193 countries. If you're eager to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family! /ppbDiversity Inclusion Policy /b /ppBSI values workforce diversity to reflect our clients and communities. We aim to foster a sense of belonging by providing growth opportunities and engaging with our global team. Everyone can thrive here. /ppbAdditional notes: /b /pulliFace-to-face interviews are conducted where feasible. If you prefer a virtual interview, inform our recruitment team. /li /ulpJ-18808-Ljbffr /p #J-18808-Ljbffr