Quality Specialist

About Traferox:
Traferox is a medical technology company transforming the field of organ transplantation. Our mission is to improve transplant outcomes and access through innovative preservation and perfusion technologies grounded in rigorous science. We are the creators of the FDA-cleared X°Port Lung Preservation System and pioneers in next generation lung perfusion systems, setting new standards in donor organ care.

Position Summary:

The position of Quality Specialist will be an integral member of the Quality and Regulatory department. The Quality Specialist will contribute to the development and maintenance of manufacturing and quality system procedures and work instructions to ensure compliance with global regulations and standards in a regulated medical device environment. The ideal candidate has at least 3 years of experience working in an Active Medical Device environment adhering to GMP with a good working knowledge of ISO 13485 and ISO 14971, FDA, EU and HC regulations. The Quality Specialist will be part of the team supporting the company-wide transition to a new facility.

Primary responsibilities include: