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 EMEAWe 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 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, and MDR (Medical Device Regulation)Initially observe audit processes, then progress to conducting audits independentlyPost-training, your weekly activities will typically include:Conducting audits onsite, remotely, or in a hybrid manner, either alone or as part of a teamWriting reports and coordinating with the planning team and delivery manager to manage clients and schedulesCompleting administrative tasks as requiredMinimum requirements:At least 4 years of hands-on experience in areas such as research and development, design or design development, servicing, maintenance/testing, or manufacturing/productionExperience with medical devices:Active devices: X-rays, Heart Lung machines, Defibrillators, MRI ScannersIVD (in vitro diagnostics) instrumentation and reagentsActive implantable devices: Cochlear Implants, MEMS systems, infusion pumps including Software as a Medical DeviceOrthopaedics: spinal implants, bone/dental cements, cartilage, soft tissue repairWound and skin care products: dressings, foams, gelsAdditional qualifications:At least 2 years' experience working with quality management systemsUniversity or technical college degree (BSc, MSc, or PhD) in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical/Electronic/Mechanical/Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or BiophysicsDo 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 wish to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family!Diversity & Inclusion Policy:BSI is committed to reflecting the diversity of our clients and communities. We aim to create a sense of belonging for all employees by providing development opportunities and fostering engagement within our global organization. Everyone can thrive here.Additional info:Our core behaviors are Client-centric, Agile, and Collaborative, guiding how we operate at BSI. We conduct face-to-face interviews where appropriate; if you prefer a virtual interview, please inform our recruitment team.J-18808-Ljbffr
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