Manufacturing Quality Engineer main purpose is to ensure that all manufacturing processes are in control and conforming to Eurofins Genomics process specification that then deliver products that meet aligned upon customer requirements.Overall Objectives and Responsibilities:Root Cause liaison for internal and external quality complaints. Leader in driving root cause analysis to identify root causes (man, method, material, measurement, machine) and put in place immediate containment, correction, and corrective actions in a timely manner. Collect Voice of the Customer (VoC) and provide details directly to customer on resolution. Demonstrates good cross functional coordination and leadership.Containment: Steps in place to contain issue and be sure that more failures are not sent to customer(s)Correction: Actions to correct the experience by customer (replace, adjust normalized product, etc)Corrective Action: Actions to address root cause of problem (change of procedure, process, additional training, etc).Lead individual assigned to Monitoring and Measuring of ProcessLead QA Check Process – store and deliver results of checks to management in reportLead Layered Process Audits – audit processes that are considered highest impact to product conformity or were identified as a potential issue based on prior non-conformancesLead QA Internal Audits - assembles and leads site-wide internal audit team to support in identification of non-conformities and works with management to close non-conformities in a timely manner.Lead Cleaning/Workplace Organization/5S Audits - audit to ensure conformance to workplace standardsIdentifies and establishes statistical process controls (SPCs) of incoming raw and in-process materials according to a risk to poor quality matrix. Develop containment/control procedures to support in actions for maintaining quality control.Daily process walks with area leaders to observe potential issues or opportunitiesInitiate action to prevent the occurrence of non-conformities related to product, processes and quality systems.Leads projects to improve the quality of manufacturing processes and productsKeeps up to date knowledge on all ISO and FDA regulatory standards, including attending sanctioned trainingsPerforms other tasks as required by Quality Manager and Quality Director
