Quality Assurance Officer
About the job
- A minimum Bac+3 qualification in biomedical sciences, quality, or an equivalent field.
- A significant initial experience in quality assurance, ideally in medical devices or a regulated environment.
- Professional proficiency in French and English, both written and spoken.
- Proficiency in Microsoft Office.
- Knowledge of Quality Management System principles.
- Knowledge of Change Control, document management, training, non-conformity, CAPA, and quality audit processes.
- Proficiency in ISO 13485 requirements.
- Rigor, attention to detail, and organization.
- Ability to work in a team and communicate effectively.
- Ability to challenge the quality of received deliverables.
- Ensure Change Requests are tracked from opening through closure and follow up on associated actions.
- Coordinate Training activities, including identifying needs, planning, tracking training, and updating records.
- Participate in Quality Management System document management and track documents requiring drafting, review, or approval.
- Update quality tracking tools and indicators within the role's scope.
- Participate in Quality Management System activities, including non-conformities, CAPA, audits, and supplier management, according to needs and priorities.
- Provide quality support to operational teams and help raise awareness of applicable procedures and requirements.
- Participate in continuous improvement actions for the Quality Management System.
- Experience with tracking tools such as JIRA.
- Knowledge of FDA 21 CFR Part 820 / QMSR requirements.
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
Growth & Insights and Company News
6 month growth
↑ 3%1 year growth
↑ 4%2 year growth
↑ 3%CorWave is developing an implantable LVAD (Left Ventricular Assist Device) driven by its proprietary breakthrough wave membrane pump technology.
CorWave announces the appointment of Dawn Sadlowski-Buisserez as Vice President of Operations to support the ramp-up of production.
CorWave announces the appointment of Fairuz Hasni as Vice President Human Resources.
CorWave, a French company specializing in the development and manufacturing of innovative cardiac assist devices, has officially opened its new facility located along the Seine River in Clichy, near Paris.
CorWave opens manufacturing facility near Paris.