Medical Devices Auditor - QMS

Medical Devices Auditor - QMS Apply locations: Italy | Posted: 30 Days Ago | Job Requisition ID: JR0016196 Great that you're considering a career with BSI! Position: Auditor Medical Devices (also known as Client Manager) Location: Italy - Field-based, with 70%-75% travel within EMEA We are seeking talented individuals to join our medical device auditing 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. Responsibilities: During the first six months as a Client Manager, you will: Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR (Medical Device Regulation) Initially observe audit procedures, then conduct audits independently Post-training, your typical weekly activities include: Conducting on-site, remote, or hybrid audits alone or in teams Preparing reports and coordinating with planning and delivery teams to manage clients and schedules Performing administrative tasks as needed Candidate Requirements: Minimum of 4 years’ hands-on experience in areas such as research and development, servicing, maintenance/testing, or manufacturing/production Experience covering medical devices such as: IVD (in vitro diagnostics) instrumentation and reagents Active Implantable Medical Devices like Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device Orthopaedics—spinal implants, cements, cartilage, soft tissue repair Wound and skin care—dressings, foams, gels At least 2 years’ experience working with quality management systems Degree in a STEM field (BSc, MSc, or PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics Do you believe the world deserves excellence? Headquartered in London, BSI is the world's first national standards organization with over 100 years of experience. We partner with over 86,000 companies worldwide. If you want to contribute to this inspiring mission, bring your enthusiasm to our team, apply now, and join the BSI family! D&I Policy: BSI is committed to workforce diversity, reflecting our clients and communities. We aim to create an inclusive environment where everyone can thrive, grow, and engage with our global organization while enjoying their work. LI-DNI Our core behaviors: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a positive workplace and business success. We conduct face-to-face interviews where feasible. If invited for an in-person interview but prefer virtual, please discuss this with our recruitment team. J-18808-Ljbffr J-18808-Ljbffr

Location: Treviso, Veneto, IT

Posted Date: 7/5/2025