Complaints Quality Engineer II - (Elkton, MD)

Job details Job Summary: The Complaints Quality Engineer II is responsible for analyses, evaluation and product investigation of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR) and other regulatory guidelines. Drives all complaint investigation activities with cross functional teammates and prepares complaint investigation reports, assigns test on retention and returned samples and write customer letters. The Complaints Quality Engineer II provides support and assistance in the evaluation of Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports. Responsible for reporting of complaints, evaluation of returned products and processing of trending analysis, in accordance with Terumo Medical Corporation procedures, and regulatory requirements.