Medical Devices Auditor - QMS
Apply locations: Italy | Posted: 30+ Days Ago | Job requisition id: JR0016196
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Position: Auditor Medical Devices (also known as Client Manager)
Location: Italy - field-based, with 70%-75% travel within EMEA
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 related to UKCA and CE marking.
Responsibilities:
First six months as a Client Manager:
* Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR
* Initially observe audits, then conduct them independently
Post-training weekly activities include:
* Conducting site, remote, or hybrid audits alone or in teams
* Writing reports and coordinating with planning and delivery teams to manage clients and schedules
* Handling administrative tasks as needed
Candidate requirements:
1. Minimum 4 years of hands-on experience in research and development, servicing, maintenance/testing, or manufacturing
2. Experience with a range of medical devices, including IVD, active implantables, orthopedics, and wound care products
3. At least 2 years of experience working with quality management systems
4. University or technical degree (BSc, MSc, PhD) in STEM fields like Biology, Chemistry, Engineering, Medicine, or related disciplines
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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 more than 193 countries. Join us and contribute to this inspiring mission!
Diversity & Inclusion Policy: BSI is committed to reflecting the diversity of our communities and fostering an inclusive environment where everyone can thrive.
Application process: We conduct face-to-face interviews where possible. If preferred, virtual interviews are available upon request.
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