Quality Engineer M/W
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.
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
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:
Compensation and logistics
Please send your CV to: email@example.com, reference « Quality Engineer ».