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 auditor team. The role involves traveling to various sites 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. Responsibilities: In 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 audits, then conduct them independently Post-training, your weekly activities will typically include: Conducting audits onsite, remotely, or in hybrid formats, independently or with a team Writing reports and coordinating with planning and delivery teams to manage clients and schedules Performing administrative tasks as needed Minimum requirements: At least 4 years of hands-on experience in areas such as research and development, design or design development, servicing, maintenance, testing, manufacturing, or production Additional experience: Experience with a range of medical devices, including: Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners IVD (in vitro diagnostics) instrumentation and reagents Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Infusion pumps, including Software as a Medical Device Orthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repair Wound and skin care products: dressings, foams, gels And at least 2 years of experience working with quality management systems. Educational qualifications include a university or technical degree in STEM fields such as Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics (BSc, MSc, or PhD). 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 across 193 countries. If you wish to contribute to this inspiring mission, bring your enthusiasm to our dynamic 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 foster a sense of belonging, offering opportunities for growth and engagement while enjoying meaningful work. Our community is one where everyone can thrive. LI-DNI Our core behaviors: Client-centric, Agile, Collaborative. These guide our actions at BSI, ensuring a great workplace and successful business. We conduct face-to-face interviews where appropriate. If invited to an in-person interview but prefer virtual, please inform our recruitment team. J-18808-Ljbffr J-18808-Ljbffr