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 travelling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits encompass standards such as ISO 9001 / ISO 13485 and schemes such as 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 (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
* Initially observe audit procedures and then conduct audits independently.
Once fully trained, your weekly activities will typically include :
* Conducting audits onsite, remotely, or in a hybrid format, either alone or as part of a team.
* Preparing reports and coordinating with the planning team and delivery manager to manage clients and schedules.
* Performing other administrative duties as required.
Minimum Requirements :
1) Minimum of 4 years of hands-on experience in areas such as :
* Research and development
* Servicing, maintenance, or testing
* Manufacturing or production
2) Experience covering various medical devices, including :
* IVD (in vitro diagnostics) instrumentation and reagents
* Active implantable medical devices such as 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 like dressings, foams, gels
3) At least 2 years of experience working with quality management systems.
4) A university or technical college 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 serve 86,000 companies and organizations across 193 countries. If you are eager to contribute to this inspiring mission, bring your open and enthusiastic mindset to our dynamic team, apply now, and join the BSI family!
Our D&I Policy: BSI is committed to reflecting the diversity of our communities within our workforce. We aim to create a sense of belonging for all employees by providing opportunities for development, growth, and engagement within our global organization, all while having fun doing great work. BSI is a community where everyone can thrive.
LI-DNI
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These core values guide how we operate at BSI, ensuring a great workplace and business success.
BSI conducts face-to-face interviews where appropriate. If invited for an in-person interview but prefer a virtual format, please discuss this with our recruitment team.
#J-18808-Ljbffr