This role sits on the Quality Assurance team and will be responsible for the development, implementation, and maintenance of QMS Design Control processes to meet the requirements of U.S. FDA (e.g. 21 CFR Part 820), and other applicable quality and regulatory standards (e.g. ISO 13485, ISO 14971).
As a Design Quality Engineer, you would have an integral role in implementing software medical device lifecycle processes and work closely with the Bioinformatics team to support regulatory submissions and compliance activities. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment. If you are looking for the opportunity to lead and make a significant contribution, this role provides an empowering and action-oriented environment to take your career and our mission to the next level.