Medical Devices Auditor - QMSApply locations: Italy | Posted: 30+ days ago | Job requisition id: JR0016196Great that you're considering a career with BSI!Role: Auditor Medical Devices (internally known as Client Manager)Location: Italy - field-based, 70%-75% travel within EMEAWe seek talented individuals to join our medical device auditor team. The role involves traveling to assess quality management systems, supporting patient safety and regulatory compliance. Our audits cover standards like ISO 9001 / ISO 13485 and schemes such as 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 MDRInitially observe audits, then conduct them independentlyPost-training, your weekly activities will typically include:Conducting audits onsite, remotely, or hybrid, individually or in teamsWriting reports and coordinating with planning and delivery teams to manage clients and schedulesPerforming administrative tasks as neededMinimum qualifications:At least 4 years' hands-on experience in research and development, servicing, maintenance/testing, or manufacturing/productionAdditional experience:Experience with a range of medical devices, including:IVD (in vitro diagnostics) instrumentation/reagentsActive implantable devices like cochlear implants, MEMS, infusion pumps, including software as a medical deviceOrthopaedics - spinal implants, cements, cartilage, soft tissue repairWound and skin care productsAt least 2 years' experience with quality management systemsEducational requirements:Degree in STEM fields such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, 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 86,000 companies across 193 countries. Join us to contribute to this inspiring mission—bring your enthusiasm to our dynamic team!DI Policy: BSI values workforce diversity, fostering a sense of belonging and providing growth opportunities for all employees. We are committed to an inclusive environment where everyone can thrive.LI-DNIOur core behaviors: Client-centric, Agile, Collaborative—these define how we operate at BSI, ensuring a great workplace and business success.We conduct face-to-face interviews where appropriate. If invited for an in-person interview but prefer virtual, please discuss with our recruitment team.J-18808-Ljbffr
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