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. We also support conformity assessments 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
* Observe audit procedures and then conduct audits independently
Post-training, your weekly activities will typically include:
* Conducting on-site, remote, or hybrid audits alone or with a team
* Writing reports and coordinating with the planning team and delivery manager
* Completing administrative tasks as needed
Minimum requirements:
Minimum 4 years of hands-on experience in areas such as:
* Research and development
* Design or design development
* Servicing, maintenance, or testing
* Manufacturing or production
Experience with a range of medical devices including:
* Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
* IVD (in vitro diagnostics): instrumentation and reagents
* Active Implantable Devices: Cochlear Implants, MEMS, infusion pumps, including Software as a Medical Device
* Orthopaedics: spinal implants, cements, cartilage, tissue repair
* Wound and skin care: dressings, foams, gels
At least 2 years' experience working with quality management systems.
Educational qualifications in STEM fields (BSc, MSc, PhD) such as Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics are required.
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 over 86,000 companies globally. If you want to contribute to this mission, bring your enthusiasm to our team, apply now, and join the BSI family!
D&I Policy:
We are committed to workforce diversity, reflecting our communities and clients. We aim to foster a sense of belonging and provide growth opportunities for all employees. BSI is a community where everyone can thrive.
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We conduct face-to-face interviews where appropriate. If invited but preferring virtual interviews, please discuss with our recruitment team.
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