Medical Devices Auditor - QMS

Location : Italy - field-based, 70%-75% of travel required within EMEA We’re looking for 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 assessment activities related to UKCA and CE marking. Responsibilities : In the first six months as a Client Manager, you will : Receive training in ISO 13485 Lead Auditor, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation) Initially observe audit procedures and then conduct audits independently After full training, typical weekly activities include : Conducting audits on-site, remotely, or in a hybrid manner, working solo or as part of a team Writing reports and coordinating with the planning team and delivery manager to manage clients and schedules Performing administrative tasks as needed To succeed, you need a minimum of 4 years of hands-on experience in areas such as : Research and development Servicing, maintenance, or testing Manufacturing or production Experience with a range of medical devices, including : IVD (in vitro diagnostics) instrumentation and reagents Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Implantable infusion pumps, including Software as a Medical Device Orthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repair Wound and skin care: dressings, foams, gels You should also have at least 2 years' experience working with quality management systems. Applicants must have completed a university or technical college degree or equivalent in a STEM field such as : Biology or Microbiology Chemistry or Biochemistry Computer and Software Technology Electrical, Electronic, Mechanical, or Bioengineering Human Physiology, Medicine, Pharmacy, Physics, or Biophysics Headquartered in London, BSI is the world's first national standards organization with over 100 years of experience. We partner with 86,000 companies across 193 countries. If you are eager to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family! Our D&I Policy: BSI is committed to reflecting workforce diversity and creating a sense of belonging for all employees by providing growth opportunities and fostering an engaging environment. We strive for a community where everyone can thrive. LI-DNI Our Excellence Behaviours: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a great workplace and business success. BSI is conducting face-to-face interviews where feasible. If invited to an in-person interview but prefer virtual, please discuss this with our recruitment team. J-18808-Ljbffr J-18808-Ljbffr

Location: Giano dell'Umbria, Umbria, IT

Posted Date: 8/22/2025