If you have an unrelenting eye for detail, a commitment to continuous improvement, and a passion for helping people, you may be the Quality Specialist that we are seeking. Our Quality Specialist is responsible for maintaining the Quality Management System in accordance with FDA Quality Systems Regulations, ISO 13485 and other applicable country-specific regulations.
As a Quality Specialist, you will work across teams in the organization to support the manufacture, testing, and release of products using controlled processes to assure that they meet all customer and regulatory requirements. In addition, our Quality Specialist is a key member of the quality improvement team, monitoring products and processes for regulatory compliance, continuous improvement and process efficiency.
PRIMARY (Essential) FUNCTIONS:
Bachelor’s Degree in a scientific or engineering field or 5+ years of experience in medical device or pharmaceutical Quality Assurance.