Quality Engineer M/W


Company description

CorWave is a medical technology startup, developing biomimetic implantable heart pumps with the goal of improving the survival and daily lives of patients with heart failure. The CorWave pump with undulating membrane is a disruptive technology protected by over 50 patents and 20 years of research. Funded by leading international investors, supported by renowned surgeons, with more than 70 employees of more than 10 different nationalities, CorWave aims to become a global leader. The “EPIC” values are at the heart of the company’s success and drive CorWavers in this scientific, medical, industrial and profoundly human adventure: Each other together, Persist with passion, Innovate for patients and Cultivate trust.

Job description

This position is responsible for supporting quality assurance and regulatory affairs activities, especially implementation and management of the CorWave Quality Management System. Primary Responsibilities: – Participate in the implementation and management of the Quality Management System. – Manage and maintain the document change order system. – Manage training process and maintain training requirements for each position within the company. – Maintain the standards database. – Participate in the risk management process for the company’s products and therapies. – Participate in quality management activities such as CAPA, internal audits, supplier management activities, etc. These activities must be performed in accordance with applicable regulatory requirements, including ISO 13485 and 21 CR Part 820.


Degree: Engineer degree / Master degree
Years of experience: At least 1 year of related experience in the following:
1. Medical device or regulated industry experience preferred.
2. Multi-functional organization
3. Document control, administration, records management or project management

Necessary skills

1. Ability to understand and interpret medical device regulations and standards and apply them in a practical and consistent manner conducive to a start-up environment.

2. Good Documentation Practices, Document control practices and change management.

3. Database management

4. Self-motivated, dependable and the ability to perform functions with limited supervision.

5. Effective communication skills, both oral and written

Would be a plus:

  • Superior attention to detail and organizational skills
  • Ability to negotiate with internal and external resources in a diplomatic manner.
  • Proficiency in Excel and ability to generate electronic metrics and displays.
  • Compensation and logistics

  • Position to be filled as soon as possible
  • Competitive salary based on skills and experience (35-40k)
  • Contact type: full-time permanent contract (CDI)
  • Location: Paris area, Clichy (métro lines 13 & 14 + shuttles, train L 6 min from Saint Lazare + shuttle)
  • Food allowance with a Swile card
  • 50% reimbursement of your Navigo pass & bike bicycle mileage costs
  • Health insurance (« complémentaire santé ») Malakoff Humanis
  • Complementary collective insurance scheme (« prévoyance »): Malakoff Humanis (100% funded by CorWave)
  • International environment
  • Please send your CV to: careers@corwave.com, reference « Quality Engineer ».

    Recruitment process

  • Pre-qualification interview (HR via Teams)
  • Onsite interview with the hiring manager and a team member
  • Interview with the CEO
  • Reference check