Medical Devices Auditor

hace 2 semanas


Madrid, Madrid, España BSI Companies A tiempo completo

Job Title: Medical Device Auditor

About the Role

We are seeking a highly skilled and experienced Medical Device Auditor to join our team. As a Medical Device Auditor, you will travel throughout EMEA, assessing quality management systems to ensure patient safety and regulatory compliance.

Responsibilities

The role involves:

  • Traveling to client sites to conduct audits
  • Ensuring compliance with standards such as ISO 9001/ISO 13485 and schemes like MDSAP, UKCA, and CE marking

In addition to conducting audits, you will also be responsible for:

  • Preparing reports and coordinating with planning and delivery teams
  • Managing clients and schedules
Requirements

To be considered for this role, you must have:

  • A minimum of 4 years' experience in areas such as research and development, servicing, maintenance, testing, manufacturing or production
  • Experience working with a range of medical devices, including IVD instrumentation and reagents, active implantable devices, orthopaedics, wound and skin care products
  • A minimum of 2 years' experience working with quality management systems
  • A university or technical degree in a STEM field such as biology, microbiology, chemistry, biochemistry, computer/software technology, electrical, electronic, mechanical, bioengineering, human physiology, medicine, pharmacy, physics, or biophysics
What We Offer

We offer a dynamic and collaborative work environment, opportunities for growth and development, and a chance to contribute to our mission of excellence. If you are passionate about delivering high-quality results and are eager to join a global organization, please apply now.


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