We are seeking a dynamic Quality/Regulatory Engineer to join our growing Regulatory Affairs/Quality Assurance (RA/QA) Department. As the Quality/Regulatory Engineer you will support and contribute to the overall Quality Management System, apply the requirements to our processes, products or services, and ensure compliance to applicable laws, regulations and standards. You will actively participate in quality improvement endeavors while working collaboratively and cohesively with employees to resolve issues. Under the supervision of Regulatory Affairs/Quality Assurance (RA/QA) Director, you will: Ensure compliance of design, development, and testing by performing gap assessment against current relevant and applicable regulations and remediation of the Design History F