Medical Devices Auditor - QMS
Apply locations: Italy | Posted: 30+ Days Ago | Job Requisition ID: JR0016196
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Position: Auditor Medical Devices (internally known as Client Manager)
Location: Italy - field-based, 70%-75% travel within EMEA required
We 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, and we support conformity assessment activities related to UKCA and CE marking.
Responsibilities:
* Undergo training in ISO 13485 Lead Auditor, MDSAP, and MDR during the first six months
* Initially observe audits, then conduct them independently
Post-training weekly activities include:
* Conducting audits on-site, remotely, or in a hybrid manner, independently or as part of a team
* Writing reports and coordinating with planning and delivery teams to manage clients and schedules
* Completing 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, or manufacturing/production
* Experience working with a range of medical devices, including:
* Active devices: X-rays, heart-lung machines, defibrillators, MRI scanners
* In-vitro diagnostics (IVD) instrumentation and reagents
* Active implantable 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: dressings, foams, gels
Additionally, at least 2 years of experience with quality management systems and a university or technical degree in a related STEM field (e.g., Biology, Microbiology, Chemistry, Bioengineering, Medicine, Pharmacy, etc.) are required.
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D&I Policy:
BSI values workforce diversity and aims to create an inclusive environment where all employees can thrive. We provide opportunities for growth and engagement within our global community.
Additional Information:
We conduct face-to-face interviews where appropriate. If invited for an in-person interview but prefer virtual, please discuss with our recruitment team.
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