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 required
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 cover standards such as ISO 9001 / ISO 13485 and schemes like MDSAP, along with conformity assessments for 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 MDR
* Initially observe audits, then conduct them independently
Post-training, your weekly activities will include:
* Conducting audits onsite, remotely, or in hybrid formats, solo or in teams
* 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, servicing, maintenance, testing, manufacturing, or production
Experience with medical devices:
* Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
* IVD (in vitro diagnostics) instruments and reagents
* Active Implantable Medical Devices: Cochlear Implants, MEMS, 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
Additional requirements:
* Minimum 2 years' experience with quality management systems
* University or technical degree in a STEM field (BSc, MSc, PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics
Join us in our mission to deliver 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're eager to contribute to this inspiring mission, bring your enthusiasm and apply now to join the BSI family!
Diversity & Inclusion Policy
BSI values workforce diversity to reflect our clients and communities. We aim to foster a sense of belonging by providing growth opportunities and engaging with our global team. Everyone can thrive here.
Additional notes:
* Face-to-face interviews are conducted where feasible. If you prefer a virtual interview, inform our recruitment team.
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