Auditors, Technical & Clinical Experts


Application

If interested, please send your Curriculum Vitae to info@mtic-group.org 

MTIC InterCert is growing steadily and successfully in all areas of Certification, particularly as a Notified Body in the area of Medical Device Certification.

Technical Experts, Lead Auditors and Auditors for Conformity Assessment activities for Medical Devices according to Directive 93/42/EC and soon, for EU Regulation 2017/745 are always welcome to cooperate with our team at our offices in Europe: activities will include both technical documentation assessments and QMS audits, including EN ISO 13485 audits.

 

MINIMUM REQUIREMENTS FROM ALL CANDIDATES

  • University degree (or equivalent qualification) in a relevant scientific or engineering discipline
  • Minimum 2 years of experience in conformity assessment activities for other NBs
  • Sound knowledge of both Directive 93/42/EC and EU Regulation 2017/745
  • Sound knowledge of the main horizontal harmonized standards including, but not limited to, EN ISO 14971, EN ISO 10993 series, EN 62304
  • Sound knowledge of harmonized standards specific to the candidate area of expertise, including, but not limited to, EN 60601-1, EN 60601-1-2, EN 60601-2-x, EN ISO 11137, EN ISO 11135, EN ISO 17665, EN ISO 11607
  • Working experience of the main manufacturing processes and technologies in the field of Medical Devices
  • Knowledge of English Language
  • Accredited training course of Auditor/Lead Auditor according to standard UNI EN ISO 19011 will be a plus

 

CURRENT SPECIFIC REQUIREMENTS

We are currently looking for the following additional specific requirements:

  • two years in the design, manufacture, testing, or use of:
    • non-active medical devices with measuring function
    • non-active ophthalmologic medical devices
    • active surgical devices

or, as alternative to the above specific requirements:

  • at least one year of experience in a Notified Body with the role of qualified technical expert for the evaluation of technical files and/or for system evaluations for at least one of the three sectors
  • at least two technical assessments carried out for the purpose of conformity assessment (assessments carried out during training are excluded)