QA/RA Specialist

Medical Device – Permanent contract 

Are you QARA expert in the field on active implants? Do you want to save patients’ lives? Would you like to be part of the pioneers in the development of a cutting-edge pacemaker solution? 

If you have a Bac +5-degree, excellent relationship building and communication skills, and you have at least 2 years of experience in a similar environment, look no further and apply with us today!

The Company

Cairdac SAS develops a pacemaker that incorporates a revolutionary energy harvesting module capable of powering the device with no energy life limitation.

In the middle of our development, we are looking for a Quality Assurance and Regulatory Affairs Engineer to assist us under the responsibility of the QARA Manager.

What You Will Do

As QA/RA Engineer, you will be playing a key role in the development and implementation of both the Quality Management System and the Regulatory Dossier for our pacemaker system.

  • Management of the Risk Management File including Usability and application of the applicable technical standards for risk reduction
  • Work closely with R&D teams to support the implementation of the DHF in compliance with regulatory requirements
  • Assist in the safety testing of the product for risk reduction to the state of the art
  • Potential overlap with validation activities such as IQ, OQ, PQ 
  • Regulatory review of technical reports
  • Assist the development, implementation, maintenance and improvement of the QMS
  • Conduct internal and supplier audits
  • Assist to audits and follow up of results
  • Work cross-functionally in identifying and resolving miscellaneous quality issues, participate in CAPA management

Who you are

Cairdac SAS ideal candidate should have experience in the development of implantable stimulators or in the field of active implants in a startup environment

You have:

  • A minimum of 3 years of hands on experience in Quality & Regulatory Affairs in active implants
  • Extensive knowledge of QMS (EN ISO 13485, 21 CFR Part 820, EN ISO 14971)
  • Familiar with technical standards (sterilization, biocompatibility, packaging, electrical safety, software..)
  • Knowledge of EN 45502
  • Excellent writing skills, both in French and English
  • Disciplined and very well organized

Apply here

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