Quality Assurance Engineer
Hybrid
Clichy, France
Full Time
03-04-2025
Job Specifications
Job Offer
Contract: 12-month Fixed-Term Contract (Full-Time)
Location: Clichy (Metro Line 13 or Line 14, RER C, Train L, Bus 74 or 341...)
Benefits: Meal vouchers (€8.50 per working day), health insurance (50% employer coverage), provident insurance (100% employer coverage), transport pass (50% employer coverage), and 25 days of paid vacation per year.
Start date: May 2024.
Company Description
CorWave is a medical technology startup developing biomimetic implantable heart pumps with the mission of improving the lives of patients suffering from advanced heart failure.
The CorWave pulsatile membrane pump is a groundbreaking technology protected by more than 50 patents and the result of 20 years of research.
Backed by leading international investors and supported by renowned surgeons, CorWave aims to become a global leader.
More than 90 CorWavers from 13 different nationalities are driving this scientific, medical, industrial, and deeply human adventure.
Recruitment Context
Are you looking for a new challenge within an innovative and dynamic company?
Join our committed team, which has transitioned from R&D to cutting-edge industrial production.
Our mission: to design and manufacture ultra-performance, reliable heart pumps dedicated to improving the lives of patients with advanced heart failure.
If you are motivated, ready to innovate, and excel in an agile environment, this adventure is made for you.
Join us, where every heartbeat makes a difference!
Job Responsibilities:
The Quality Assurance Engineer demonstrates quality in all actions:
Ensure compliance to QSR and ISO 13485 requirements
Documents root cause analysis of non-conforming product, in concert with other departments
Reviews and approvals of DMR and DHF documents
Evaluates change orders to ensure accuracy of documentation, appropriate testing is performed, and the appropriate impacts are considered
Review, provide feedback and approve process validations reports (IQ, OQ, PQ) with Operations team
Review, provide feedback and approve design verification and validation reports with Research, Design and Software teams
Works closely with R&D and Operations to support risk analysis activities
Supports creation of QMS according to ISO 13485
Required Knowledge, Skills, Abilities
Must possess good communication (verbal & written) skills and analytical problems solving skills
Strong computer skills in MS Office products (Excel, Word, PowerPoint)
Ability to work effectively in a team environment
Required Education/ Experience
BS Engineering, math or closely related field required
Minimum 5 years experience in QA/RA in medical device manufacturing
Strong working knowledge of QSR and ISO requirements
Demonstrated experience in Risk Analysis, Statistical techniques, FDA, QSR, ISO13485, 21 CFR Part 820
Experience should include competency in evaluating new quality plans
Preferred Experience
Ability to communicate with technical and non-technical personnel
Ability to prioritize/schedule activities to meet department's goals and objectives
About the Company
CorWave is a French company developing innovative cardiac assist devices. CorWave’s wave membrane pump is a breakthrough technology that differs from today’s commercially available left ventricular assist devices (LVADs) by its physiological operation, designed to mimic a pulse and blood flow rates similar to those of a healthy heart. Ultimately, CorWave’s membrane pump technology is expected to reduce the complications associated with current devices and improve the management of heart failure patients. A member of the Fr... Know more
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