EKF is seeking a Quality Design Assurance Specialist to support medical device design control activities in a temporary, remote-based role.

Responsibilities include reviewing and remediating Design History Files, creating and updating design control documentation, supporting risk management, and ensuring compliance with FDA and ISO 13485 requirements. Candidates should hold a bachelor’s degree, have 4+ years’ experience in medical device quality or design assurance, and possess strong regulatory knowledge and documentation skills.