QA / Regulatory Affairs Engineer

Change the face of robotics with us.

https://enchanted.tools

At Enchanted Tools, we are bringing a new generation of robots to life.
Combining world-class engineering expertise and the power of imagination, we plan to make everyone’s life better with robotic characters. Our robots can glide, grasp and interact with their environment, tackling concrete issues and needs.

Founded in 2021, we are now 100 enchanters, working in different fields (Robotics, AI, Product design, Project Management, Production, Quality, Supply chain, Finance, Marketing, HR, Sales, ...) and we keep growing, thanks to our strong relationships with a variety of investors and partners.

We revealed our two prototypes to the world and are now ready for the next steps of our adventure: industrialize our production, starting with a pilot line at the heart of Paris, then building a plant ; and selling our robots at a global scale. We built a whole ecosystem and rely on well-established partnerships to achieve our ambitious projects. We are looking for passionate, creative and curious experts to join us. 

Why you should join us:

• You will have a unique opportunity to work on next-gen robots, cracking technological lockers of interaction, grasping, and navigation;

• You will be an early player of a super ambitious and fast-growing adventure, that proved its ability to turn dreams into reality;

• Our team are all experts in their field, coming from diverse and international backgrounds

You will be integrated to the Industrialisation team.

As a QA/RA Engineer at Enchanted Tools, your missions will be to :

• Structure the database of all applicable laws, regulations, and standards requirements

• Identify the functional / constructional requirements applicable to the robot (Context: Machinery directive, Electrical safety, Electromagnetic compatibility, Radio frequency, Cybersecurity, …)

• Define the roadmap to achieve our certification’s goal (CE, FDA, …)

• Ensure continual visibility to the R&D over the applicables regulatories

• Through the adapted validation plan ensure that the company establishes controls and/or completes necessary activities to ensure compliance.

• Take over the robot's risk analysis and participate in design review sessions to ensure that the product design improvements are lined up with the risk analysis.

• Provide Quality Management System guidance to the product team and ensure that the proper activities are completed in time and documented correctly. Follow corrective actions when required

• Complete and update the certification product dossier

• 5 years experience in a quality department, and regulatory affairs

• A background in robotics or complex mechatronic systems would be an asset

• Experience with quality systems regulations, ISO/IEC and European/American/Japanese standards, information privacy and security, environmental controls

• Be well versed in all aspects of Design Controls, Risk Management, and all associated processes, policies, procedures, and records

• Good public speaking communication skills

• Analytical mind