New

Quality Engineer

bioMerieux Inc.
United States, Pennsylvania, Philadelphia
3711 Market Street (Show on map)
Mar 11, 2025
Description The QA Engineer is responsible for supporting and facilitating the quality management system of the bioMerieux Philadelphia site. Under the guidance of the Quality Manager, the QA Engineer will work collaboratively with other departments including manufacturing, R&D, and purchasing to ensure compliance to the quality management system. Additionally, this position will assist in executing various site-wide quality projects and initiatives. The incumbent is responsible for monitoring site activities to ensure appropriate quality reporting and compliance to ISO9001:2015 standards. The QA Engineer will have a specific focus on supplier quality management, risk analysis of site processes, continuous process improvement, and sustaining quality management system activities. Job Responsibilities: Work within the framework of the site quality management system to ensure compliance across the operation. Assist other departments and employees with initiating and completing quality event documentation including: nonconformances, temporary deviations, and corrective and preventative actions (CAPA). Collaborate with the purchasing department to validate and approve suppliers and maintain records associated with the supplier quality management process. Performs a wide variety of inspection, risk mitigation, and audit activities. Responsible for maintaining site-wide quality assurance KPIs. Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards. Cooperate with the rest of the Quality team to address quality-related projects and initiatives across the site. Support the quality assurance team with routine work centered around continuous process improvement using a risk-based approach. Minimum Requirements: HS Diploma and a minimum of 5 years of experience years of experience in a quality-regulated manufacturing industry required. OR Associates and a minimum of 4 years of experience in a related field will be accepted in lieu of the degree OR BA/BS Degree in a life science or related field and a minimum of 3 years of experience in a quality-regulated manufacturing industry required. OR Masters' degree with 1 year or more of experience preferred. Prior experience with Quality Management System procedures support in a quality department preferred. Familiarity / knowledge of the interpretation and application of relevant domestic and international regulations and industry standards (ISO9001, ISO13485, ISO17025) is preferred. Experience managing nonconformances, deviations, corrective / preventative actions, and investigation writing preferred Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.