Location : Spain - field-based, 70%-75% of travel required within EMEA
We’re looking for 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 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.
* Initially observe audits and then conduct them independently.
After full training, in a typical week you will:
* Conduct onsite, remote, or hybrid audits alone or in teams.
* Draft reports and coordinate with the planning team and delivery manager regarding clients and schedules.
* Perform other administrative tasks as needed.
Minimum Requirements :
1) At least 4 years of practical experience in one or more of the following fields:
* Research and development
* Servicing, maintenance, or testing
* Manufacturing or production
2) Experience covering various medical devices, such as:
* IVD (in vitro diagnostics) instrumentation and reagents
* Active Implantable Medical Devices, including software (e.g., cochlear implants, MEMS systems, infusion pumps)
* Orthopaedics (spinal implants, cements, cartilage, tissue repair)
* Wound and skin care products (dressings, gels, foams)
3) At least 2 years' experience working with quality management systems.
4) A university or technical degree in a STEM field such as Biology, Microbiology, Chemistry, Biochemistry, Computer Science, Electrical, 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 serve 86,000 companies in more than 193 countries. If you’re eager to contribute to this mission, bring your enthusiasm to our team, apply now, and join the BSI family!
BSI is committed to diversity and inclusion, aiming to reflect our clients and communities. We strive to create a supportive environment where everyone can thrive.
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Our core behaviors: Client-centric, Agile, Collaborative. These guide how we operate at BSI, ensuring a positive workplace and successful business.
We conduct face-to-face interviews where possible. If invited but preferring virtual interviews, please discuss with our recruitment team.
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