Quality Control Engineer
il y a 6 jours
**Quality Control Engineer**:
Robeauté is redefining the future of neurosurgery with self-propelled microrobots designed to navigate the human brain with unprecedented precision. Our technology makes it possible to reach deep brain regions that were previously inaccessible, without invasive surgery.
We’ve developed microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments.
Since our founding in 2017, we’ve filed 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2026. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth.
Now, as we scale, we are looking for a **Quality Control Engineer** to ensure the safety, reliability, and compliance of our microrobotic systems through rigorous inspection, calibration, and documentation practices.
**What you’ll do**:
**Quality Control Operations**:
- Design and implement **quality control activities**, processes, and associated documentation (procedures, work instructions, forms).
- Perform **incoming, in-process, and final inspections** on components and finished medical devices.
- Manage **clean room monitoring and surveillance**, ensuring compliance with environmental and microbiological standards.
- Oversee **external service providers** for microbiological and sterilization activities.
- Lead **equipment qualification** activities (IQ/OQ/PQ), internally or with suppliers.
- Define and execute **equipment calibration** and **metrology activities** in line with the calibration schedule.
- Ensure full **traceability and documentation** of QC activities within the Quality Management System (QMS).
**Compliance & Continuous Improvement**:
- Monitor and analyze **quality KPIs**, identify trends, and propose improvements.
- Manage **quality control events** including nonconformities, change controls, and CAPAs.
- Participate in **internal and external audits**, contributing to continuous improvement initiatives.
- Ensure product compliance with **ISO 13485** and other relevant standards (e.g., ISO 17025, GLP, ICH).
**Collaboration & Mentorship**:
- Collaborate closely with **Production, R&D, and Quality Assurance** to ensure product and process compliance.
- Provide **technical guidance and mentoring** to QC technicians.
- Support cross-functional teams in maintaining high standards of safety, reliability, and performance.
**Requirements**:
**Technical Skills**
- Strong knowledge of **ISO 13485**, and familiarity with ICH, ISO 17025, GLP.
- Hands-on experience with **equipment calibration**, **IQ/OQ/PQ qualification**, and **dimensional/mechanical testing**.
- Proficiency in **measurement techniques**, **metrology**, and **documentation practices**.
- Experience in **microbiological testing** and **clean room management** is a plus.
**Personal Attributes**
- Detail-oriented, analytical, and rigorous.
- Proactive and autonomous, with strong problem-solving skills.
- Team-oriented and capable of working cross-functionally.
- Strong written and verbal communication skills in **French and English**.
**Education and Experience**
- Master’s or Engineering degree in **Quality**, **Metrology**, **Mechanical**, **Biomedical**, or related field.
- Minimum **3 years of experience** in Quality Control or Metrology within **medical devices**, **pharma**, or **biotech**.
**Benefits**
**A Mission That Matters**: Join a team developing life-changing technology. Our microrobots have the potential to help over **1 million patients** with neurological conditions.
**World-First Innovation**: Work on pioneering microrobots that navigate the brain for diagnosis and treatment—mínimally invasive, maximum impact.
**An Exceptional Team**: Collaborate with leading engineers, clinicians, and researchers pushing the boundaries of medical robotics and neurotechnology.
**Real Ownership**: Join a well-funded deeptech startup backed by top investors. Shape your domain, drive strategic decisions, and grow with us.
**Also**:
**Alan Health Insurance** — One of France's most innovative health insurance providers. We happily cover 60% of the cost.
**Meal Vouchers** — €9.25 per day, 60% covered by the company.
**Transportation Reimbursement** — 50% of your commuting costs covered.
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