Medical Devices Auditor - QMSApply locations: Italy | Posted: 30+ Days Ago | Job Requisition ID: JR0016196Great 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 requiredWe are seeking 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 include 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, and MDRInitially observe audits and then conduct them independentlyAfter full training, your weekly tasks will include:Conducting audits onsite, remotely, or in a hybrid manner, independently or as part of a teamWriting reports and coordinating with planning and delivery teams to manage clients and schedulesCompleting administrative activities as requiredMinimum qualifications and experience:At least 4 years of hands-on experience in research and development, servicing, maintenance, testing, manufacturing, or productionPreferred experience:Experience with a range of medical devices, including:IVD (invitro diagnostics) instrumentation/reagentsActive Implantable Medical Devices such as Cochlear Implants, MEMS systems, Implantable infusion pumps, including Software as a Medical DeviceOrthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repairWound and skin care: dressings, foams, gelsAt least 2 years of experience working with quality management systems.Educational requirements:Degree or equivalent in a STEM field 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 86,000 companies in over 193 countries. Join us and contribute to this inspiring mission!Equal Opportunity Policy:BSI values diversity and aims to create an inclusive environment. We provide opportunities for growth and engagement within our global organization.Additional Information:We conduct face-to-face interviews where appropriate. If invited but more comfortable virtually, please discuss with our recruitment team.J-18808-Ljbffr
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