Quality Engineer - QMS M/F
Company Description Now a member of the Precision IO group, at Quantum Surgical, we are a company specializing in medical robotics and artificial intelligence. Our percutaneous ablation robotic platform, Epione®, is dedicated to the curative and early treatment of cancers. We thus offer a new approach to cancer treatment by standardizing access to care. More patients can thus benefit from innovative, better-targeted, and less invasive treatments. More than 1,400 patients have already been treated worldwide. We recently acquired NeuWave Medical. Together, our two companies now operate under the aegis of the group's new identity: Precision IO, with the ambition to transform standards of care in tumor ablation and interventional oncology through innovation. Job Description As a QMS Quality Engineer, you will work with another QMS Quality Engineer, reporting to the QMS & Production Quality Manager, within a QARA team of +10 people. You will contribute to ensuring the compliance and continuous improvement of the company's Quality Management System in accordance with the ISO 13485:2016 standard and other regulations applicable to the medical device industry. This position is based in Montpellier. Your missions will be as follows: Support the site's quality system activities to ensure compliance with the requirements of the ISO 13485 standard, the FDA, the QSR, and 2017/745 regulations.
Develop and maintain all necessary quality procedures and documents.
Promote quality values and continuous improvement by participating in and supporting employee quality training.
Responsible for document control activities, supplier reassessment, and follow-up activities.
Review and control DHR before products are placed on the market.
Support non-conformity activities towards their resolution.
Support CAPA activities towards their closure.
Establish, monitor, measure, and communicate key quality performance indicators.
Participate in audit activities (internal and external) and ensure follow-up.
The missions of the position may evolve with the growth of the company and various upcoming projects. Profile Sought Required You hold an Engineering degree or equivalent.
You have a minimum of 5 years of experience as a Quality Engineer.
You have a good level of English (oral and written).
You have experience in a CE regulated environment or in an environment with a high level of requirements.
You are rigorous, organized, and possess synthesis and analytical skills.
You are able to communicate effectively and establish relationships with internal and external stakeholders.
You have excellent organizational and communication skills.
You have a strong team spirit. Desirable You have skills in problem-solving methods.
You have experience in operational quality.
You have experience in supplier quality assurance.
You are proficient in the ISO 13485 or ISO 9001 standard.
You have experience in the medical device industry or an equivalent sector. Working at Quantum Surgical (Precision IO Group) means: Joining a talented and creative multicultural team, and participating in the technological and human adventure of a rapidly growing company.
Sharing our values of innovation, teamwork, and a results culture.
Taking on stimulating technical challenges.
Benefiting from competitive compensation and benefits (Fixed salary + variable, Swile meal vouchers, WellPass).
A teleworking policy of up to 2 days per week. Recruitment process: Pre-selection interview (Teams video) - HR – 30/45 minutes
Technical interview (Teams video) – QMS & Production Quality Manager & HR – 30/45 minutes
Interview at our premises – QARA Director, QMS & Production Quality Manager & HR - 1h/1h30
Diversity is an integral part of our values. Therefore, we study all applications with interest without distinction that may be linked to a physical or moral characteristic. The compensation range mentioned in this advertisement includes both the fixed and variable parts. Website: https://quantumsurgical.com/ Company video: https://www.youtube.com/watch?v=mZmC3-KcrtM