Quality Engineer - Manufacturing Quality Operations

Overview

Quality Engineer - Manufacturing Quality Operations is a key individual contributor in the Quality Operations organization, responsible for executing quality management system (QMS). Primary responsibilities include reviewing and dispositioning quality records associated with equipment controls against the governing procedural requirements, and performing acceptance activities including incoming and finished product release following the applicable procedural requirements. This individual contributes to a positive environment of accountability and performance excellence.

• Support Quality Operations through execution of quality engineering concepts and principles in accordance with quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations and standards.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others.
• Complete assignments timely and of high quality, effectively communicating status and issues with management.
• Facilitate equipment qualification as well as related activities as assigned.
• Support acceptance activities including incoming inspection and finished product inspection focusing on the Raleigh, NC site and other activities as assigned.
• Other duties as assigned.

• Bachelors degree in science, engineering, or other technical area.
• Minimum of 5 years of experience working within a medical device, pharmaceutical, or biotech quality management system.
• Experience working with in vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements.
• Strong written and verbal communication skills.
• Ability to comprehend and interpret technical information.