Responsable Qualité Industrielle
About the job
- A degree at engineering level (Bac +5 or equivalent), ideally in engineering, quality, or an equivalent domain.
- At least 10 years of industrial quality experience, including 5 years managing a team, with significant experience in the medical-device industry.
- Excellent written and spoken French and English in an international environment.
- Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
- Mastery of ISO 13485, MDR, and FDA 21 CFR Part 820 requirements.
- Substantial experience in inspection, non-conformance management, CAPA, and internal and external audits.
- In-depth knowledge of industrial processes and quality controls for implantable medical devices.
- Ability to analyze, structure, and improve quality processes in a regulated environment.
- Ability to lead cross-functional projects and communicate effectively.
- Ability to lead and mobilize a team around a project.
- Rigor and organizational skills.
- Lead industrial quality, from incoming inspection control through monitoring and resolution of operational non-conformances.
- Lead incoming inspection of components, raw materials, and purchased products, ensuring their conformity before release to production.
- Lead metrology, including management of the instrument inventory, calibration and verification follow-up, and handling metrology non-conformances.
- Lead the handling of production-related non-conformances and CAPAs.
- Supervise batch record reviews (DHR) and release batches in accordance with quality procedures and regulatory requirements.
- Ensure industrial activities are compliant and prepared for ISO 13485, MDR, and FDA audits.
- Define and monitor quality KPIs, analyze trends, and lead improvement plans.
- Supervise and lead the Industrial Quality team.
- Organize the team’s workload, priorities, and schedules in line with production needs.
- Communicate quality priorities across Operations and promote a Quality First culture.
- Maintain and continuously improve the QMS within the team’s scope, including procedures, work instructions, forms, and records.
- Contribute to process risk analyses (PFMEA), process validations (IQ/OQ/PQ), and industrial transfer activities.
- Participate in continuous-improvement projects and digitalization of quality-control activities.
- Experience in a startup or innovative small or medium-sized enterprise is appreciated.
About the company
Corwave develops implantable cardiac support devices to help heart failure patients. Its main product is an implantable heart pump that uses wave membrane pumping technology, where an oscillating membrane displaces fluid to move blood. This design aims to provide pulsatile blood flow while enabling a less invasive surgical approach due to its compact, membrane-based mechanism. Compared with traditional ventricular assist devices, Corwave emphasizes its unique wave membrane pumping method and tubular membrane components to deliver controlled blood flow with fewer procedural burdens. The company’s goal is to improve outcomes and reduce suffering for patients by offering durable, implantable cardiac support that lowers the pain and risks associated with invasive surgery.
Company Size
51-200
Company Stage
Series C
Total Funding
$112.7M
Headquarters
Clichy, France
Founded
2012
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Simplify's Take
What believers are saying
- On July 9, 2025, CorWave implanted its first patient and hit the 30-day endpoint.
- September 29, 2025 results showed no device-related serious adverse events at 30 days.
- CorWave plans at least four patients before pivotal trials, keeping clinical momentum alive.
What critics are saying
- CorWave still has only one implanted patient, leaving pivotal efficacy unproven in 2026.
- Medtronic, Abbott, and Berlin Heart dominate LVAD adoption, squeezing CorWave's reimbursement and surgeon mindshare.
- A failed pivotal trial kills CorWave's platform before commercialization.
What makes Corwave unique
- CorWave’s wave-membrane LVAS preserves pulsatility, unlike rotary pumps, and targets native-heart physiology.
- ISO 13485 certification on May 28, 2026 validates manufacturing quality across operations.
- Its Clichy manufacturing plant and clinical-stage team support integrated development and production.
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Benefits
- Meal Benefits
- Health Insurance
- Disability Insurance
- Commuter Benefits
- Paid Vacation
- Paid Holidays
- Flexible Work Hours
- Remote Work Options