Quality Engineer
The Quality Engineer is the central quality contact for our organisation, responsible for ensuring the highest standards of quality in all aspects of our operations.
Main Responsibilities:
* Manage quality documentation for design and manufacturing processes, ensuring compliance with regulatory requirements.
* Lead risk management activities, both internally and with suppliers, to identify and mitigate potential risks.
* Develop and implement inspecting and testing procedures to guarantee product quality.
* Oversee product batch release, ensuring that only high-quality products reach the market.
* Analyze data to inform quality-related decisions and drive business improvement.
* Support training activities to upskill colleagues and promote a culture of quality excellence.
* Lead the implementation and maintenance of our Quality System, compliant with ISO 13485 standards.
Requirements:
* Master's degree in Mechanics, Bio-medical Engineering, or a related field.
* A minimum of 5 years of experience in Quality Management within the medical devices industry, preferably with Class III products.
* Expertise in Medical Device standards, including ISO 13485 and MDR 2017/745.
* Strong analytical skills to interpret data and drive decision-making.
* Ability to work autonomously in a fast-paced startup environment.
* Proficiency in French and English languages.
Estimated Salary: €60,000 - €80,000 per year