Location : Spain - field-based, 70%-75% of travel required within EMEA
We’re 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 assist with conformity assessment activities 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 (Medical Device Regulation).
* Initially observe audits, then conduct them independently as you gain experience.
Once fully trained, your typical week will include :
* Conducting audits onsite, remotely, or in a hybrid manner, alone or with a team.
* Preparing reports and coordinating with the planning team and delivery manager to manage clients and schedules.
* Performing administrative tasks as needed.
Minimum Requirements :
1) At least 4 years of hands-on experience in one or more of the following areas :
* Research and development
* Servicing, maintenance, or testing
* Manufacturing or production
2) Experience with a range of medical devices, such as :
* IVD (in vitro diagnostics) instrumentation and reagents
* Active implantable devices like 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 products - dressings, foams, gels
3) At least 2 years' experience working with quality management systems.
4) A university or technical degree (BSc, MSc, or PhD) in a related STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer and 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 across more than 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!
BSI is committed to diversity and inclusion, reflecting the communities we serve. We aim to create a sense of belonging by offering opportunities for growth, development, and engagement within our global organization, all while having fun doing meaningful work. Everyone can thrive at BSI.
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Our core behaviors are Client-centric, Agile, and Collaborative. These guide how we operate at BSI, ensuring a great workplace and successful business.
We conduct face-to-face interviews where appropriate. If invited to an in-person interview but prefer a virtual one, please discuss this with our recruitment team.
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