Since our creation in 2016, our team continues to grow. This growth brings together talents from many different backgrounds around a common desire and a shared mission; to make life easier for patients suffering from heart rhythm disorders. To carry out our mission, we are always looking for enriching new talents to welcome in our team!
If you want to join a talented and dynamic team fascinated by cardiac rythme management and technology, CAIRDAC is definitely the place for you.
You will be part of a multidisciplinary team in the field of medical engineering. You’ll be working on innovative and high tech implantable products. From this perspective, the missions will be as follows:
Participate in the development of innovative products
Assemble sub-assembly and complete products
Perform product tests
Prepare and perform laboratory tests
Participate in the development of test procedures in collaboration with the electronics and mechanics engineering teams
Analyze the results in coordination with the Design Office
Participate in the continuous improvement of assembly processes and tools
Study the industrial feasibility of the assembly process to ensure the cost-effective manufacturing of products
Validate processes by creating digital and / or physical layouts
Organization of industrial systems & logistics
Participate in the writing and updating of technical documentation
Evolve in a quality and normative system in English (ISO 9001, ISO 13486)
Bac +2 or equivalent
Contract and Salary
Salary according to diploma and experience
Some travel required
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!
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
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
If you do not see a job description that match your strengths and skills, but would like to be part of our team, please send us your resumé and cover letter. We are always looking for talented people to join out team.