Quality Assurance Engineer

Description

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.