DHR Quality Control Technician M/F/X

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 within the group: Precision IO, with the ambition to transform standards of care in tumor ablation and interventional oncology through innovation.

Job Description

As a DHR Quality Control Technician, you will work within the QMS & Production Quality team, alongside another DHR Quality Control Technician and the Incoming Quality Control Technician, reporting to the QA Production Manager, within a QARA team of +10 people.

You will contribute to ensuring the compliance of devices before their release, by ensuring the review of Device History Records (DHR) and final quality control activities, 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:

• Perform the review of Device History Records (DHR) before device release, in accordance with the requirements of the ISO 13485 standard, the FDA (QMSR), and EU regulation 2017/745.
• Verify the compliance and completeness of production records (batch records, control records, component traceability) prior to product release.
• Perform final quality controls on robotic platforms and their accessories before shipment.
• Identify, document, and escalate non-conformities detected during the DHR review or final quality control.
• Contribute to the monitoring of deviations (Concessions) and reworks (Reworks).
• Contribute to the monitoring of SCNR (Supplier/Site Corrective Non-conformance Report) detected during the manufacturing process.
• Fill in and maintain up-to-date quality records associated with product release activities.
• Contribute to the continuous improvement of final control and DHR review processes (reliability, lead times, efficiency).
• Monitor and communicate quality performance indicators related to product release (compliance rate, processing times).
• Participate in audit activities (internal and external) related to the product release process.
• Act as the Quality interlocutor for production teams: team awareness, support for improvement actions, and assistance in problem-solving.

The missions of the position may evolve with the growth of the company and various upcoming projects.

Profile Sought

Required

• You hold a BAC+2 / BAC+3 degree (type BTS, DUT, Licence).
• You have a minimum of 5 years of experience in a similar position.
• You are proficient in the ISO 13485 or ISO 9001 standard.
• You have a good level of technical English (oral and written).
• You have experience in a CE regulated environment or an environment with a high level of requirements.
• You are rigorous, organized, and possess strong synthesis and analytical skills.
• You are able to communicate effectively and establish relationships with internal and external interlocutors.
• 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 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 company in full bloom.
• Sharing our values of innovation, team spirit, and a results-oriented culture.
• Taking on stimulating technical challenges.
• Benefiting from competitive compensation and benefits (Fixed salary + variable, Swile meal vouchers, WellPass).

The recruitment process:

1. Pre-selection interview (Teams video) - HR – 30/45 minutes
2. Technical interview (Teams video) – QMS & Production Quality Manager & HR – 30/45 minutes
3. 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 related to a physical or moral characteristic.

The compensation range mentioned in this advertisement includes both the fixed and variable components.

Website: https://quantumsurgical.com/

Company video: https://www.youtube.com/watch?v=mZmC3-KcrtM