- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
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Quality Control Engineer - Paris - Robeaute
Description
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
Compliance & Continuous Improvement
Collaboration & Mentorship
Technical Skills
Personal Attributes
Education and Experience
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—minimally 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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