Production Quality Manager 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 1,800 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

To support the ramp-up of Epione® production, we are looking for our Production Quality Manager.

Reporting to the Quality Manager QMS & Production, you are the guarantor of the compliance of what leaves our lines and the daily support point for the industrial teams.

You will manage a team of Quality Technicians.

This position is based in Montpellier.

Your missions will be as follows:

• Supervise the quality of Epione® production operations and its consumables, from incoming inspection to final release: incoming inspection, in-process controls, review of Device History Records (DHR), and release before shipment.
• Validate the effective implementation of DMR (Device Master Record) in Production before their application.
• Drive the processing of production non-conformities: investigation, root cause analysis, deviations, rework, and management of associated CAPA.
• Participate in monthly boards regarding CAPA and product non-conformities;
• Supervise, train, and develop the skills of the quality technician team (incoming inspection and production control).
• Participate in supplier selection/qualification and re-evaluation activities.
• Be the daily quality interlocutor for Production, Design Transfer, and Supply Chain: arbitrate blockages, secure decisions, and hold the line when necessary.
• Contribute to the validation activities of production processes and equipment (IQ/OQ/PQ) as well as the qualification of control tools, in connection with Design Transfer and R&D.
• Ensure control of the production environment and compliance with good documentation practices.
• Define, monitor, and manage production quality indicators (non-conformity rate, scrap, first pass yield, NC processing time) and use them as a lever for continuous improvement.
• Support Production in the implementation of improvement actions.
• Raise awareness among operational teams regarding Quality requirements through inspection and training activities.
• Represent production quality during internal and external audits (ISO 13485, MDSAP, notified body, FDA) and during the production transfer of new products.

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 a Master's degree (generalist, mechanical, quality, or biomedical).
• You have a minimum of 5 years of experience in operational quality in a regulated industrial environment (medical device, pharmaceutical, aeronautics), including initial experience in team management or leadership.
• You master field quality tools: root cause analysis (8D, Ishikawa, 5 Why), non-conformity management, CAPA, process validation.
• You are familiar with ISO 13485 and 21 CFR Part 820 (QMSR) requirements applied to production, and you have already been on the front line during an audit.
• You know how to uphold a quality decision against schedule pressure, and explain it without alienating your interlocutors.
• You have professional English proficiency in both written and spoken forms: you interact daily with our teams in the United States.

Desirable

• You have worked on Class IIb or III medical devices, or in medical robotics.
• You are familiar with the requirements of Regulation (EU) 2017/745 (MDR) and/or medical device software validation (IEC 62304).
• You have already supported an industrial transfer of a new product (NPI) from R&D to production.
• You practice Lean / Six Sigma methods (Green Belt or equivalent).
• You are comfortable with an eQMS and an ERP.

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-oriented 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 1 day per week: the position requires a strong presence on the ground.

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 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