C

Corwave

Implantable heart pump for heart failure

Quality Engineering Manager

Quality EngineeringConfirmed live in the last 24 hours
Full-timeClichy, FranceNo salary listed

About the Job

Requirements

  • A Bac+5 engineering degree in quality, industrial engineering, mechanical engineering, materials, biomedical engineering, or an equivalent field.
  • At least 8 years of experience in an industrial environment, including at least 5 years in operational quality in the medical-device sector, and significant team-management experience.
  • Fluent French and English, written and spoken.
  • Hands-on experience managing nonconformities, CAPA, complaints, inspection, and product release.
  • Knowledge of ISO 13485, MDR, and 21 CFR Part 820 (QMSR).
  • Ability to lead cross-functional projects, communicate effectively, and mobilize a team around a project.
  • Strong organizational skills and rigor.

Responsibilities

  • Lead the Industrial Quality team responsible for operational quality, including incoming inspection, in-production inspection, nonconformity management, and CAPA.
  • Manage, develop, structure, and recruit the team; organize workload, priorities, and schedules in line with production needs; and promote quality priorities and a Quality First culture across Operations.
  • Spend at least half of working time on the production and quality-control floor.
  • Lead incoming inspection of components and materials, in-production inspection, and metrology, including digitizing inspection activities.
  • Work closely with Production, Industrialization, Supply Chain, Research and Development, and Regulatory Affairs on nonconformities and CAPA; supplier nonconformities identified at incoming inspection are handled with Supplier Quality, which leads SCARs.
  • Oversee batch-record review (DHR) and block a batch when there is a quality concern.
  • Review and approve equipment qualifications and process validations (IQ/OQ/PQ and TMV), contribute to PFMEA, and support industrial transfers.
  • Maintain and continually improve procedures, work instructions, forms, and records for the assigned QMS scope.
  • Anticipate and ensure compliance with ISO 13485, MDR, and FDA requirements, and prepare the scope for audits.
  • Track quality KPIs, analyze trends, and define improvement plans.

Desired Qualifications

  • Experience with implantable or Class III medical devices.
  • Experience with notified-body or FDA audits.
  • Experience in a start-up, scale-up, or industrial ramp-up.

About the Company

Corwave

Implantable heart pump for heart failure

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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