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 like ISO 9001 / ISO 13485 and schemes such as MDSAP, as well as conformity assessments related to UKCA and CE marking.
Responsibilities:
Initial Six Months:
* Receive training in ISO 13485 Lead Auditor, MDSAP, and MDR
* Observe audit procedures and gradually conduct audits independently
After Full Training (Typical Week):
* Conduct on-site, remote, or hybrid audits independently or with a team
* Prepare reports and coordinate with planning and delivery teams to manage clients and schedules
* Perform administrative tasks as needed
Qualifications:
* Minimum of 4 years' experience in research & development, design, servicing, maintenance, testing, manufacturing, or production
Experience with Medical Devices:
* Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
* IVD instrumentation and reagents
* Active Implantable 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
* At least 2 years' experience with quality management systems
* Degree in STEM field (BSc, MSc, PhD): Biology, Microbiology, Chemistry, Biochemistry, Computer/Software Technology, Electrical, Electronic, Mechanical, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics, or Biophysics
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 86,000 companies in over 193 countries. If you want to contribute to this inspiring mission, bring your enthusiasm to our dynamic team, apply now, and join the BSI family!
Diversity & Inclusion Policy:
BSI is committed to workforce diversity, reflecting our clients and communities. We aim to create a sense of belonging by providing growth opportunities and engaging with our global organization while having fun. Everyone can thrive here.
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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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