Quality Engineer

The Operations Quality Engineer collaborates with customers and manufacturing teams to quickly resolve issues identified during Receiving Inspection (RI) and production processes. This role focuses on continuous improvement and error-proofing to ensure efficient and effective manufacturing operations. Key responsibilities include managing and analyzing Nonconforming Material Reports (NCMRs), customer complaints, and Supplier Corrective Actions (SCARs), conducting root cause investigations, and implementing Corrective and Preventive Actions (CAPA). The engineer will also develop and execute process validation protocols (IQ/OQ/PQ) and support process risk management activities such as pFMEA. Responsibilities: Serve as the operations quality representative for customers when projects transition into manufacturing. Support design transfer activities, confirm production readiness, and ensure quality requirements are properly implemented. Lead investigations and reporting for NCMRs, customer complaints, and CAPA, including troubleshooting manufacturing issues and ensuring compliance with procedures and requirements. Work with suppliers to address NCMRs and SCARs, escalating issues to Supplier Quality Engineering when necessary. Participate in cross-functional teams to review and determine disposition of nonconforming products or components. Contribute to cross-functional efforts to develop process validation and risk management documentation, including IQ/OQ/PQ protocols and reports and pFMEA files. Review Device History Record (DHR) documentation for accuracy, completeness, and adherence to Good Documentation Practices (GDP). Provide guidance to project teams on quality policies and procedures, including verification, validation, statistical methods, and manufacturing controls. Assist with training related to Special Work Orders (SWOs), Receiving Inspection processes, and First Article Inspections (FAI) as needed. Develop and implement error-proofing solutions (poka-yoke) to reduce defects and improve manufacturing processes. Support internal and process audits and lead assigned audit activities when required. Qualifications: Strong knowledge of manufacturing operations and quality systems within a medical device environment. Understanding of ISO 13485 and FDA QSR requirements, including root cause analysis, risk management, and process validation. Ability to perform Root Cause Analysis (RCA) by defining problems, gathering data, analyzing facts, and forming valid conclusions. Experience with eQMS systems, ideally Grand Avenue Software (GAS). Knowledge of error-proofing methods (poka-yoke) and their application in manufacturing. Advanced proficiency with Microsoft Office (Word, Excel, Access, PowerPoint), internet, and email tools. Ability to prioritize tasks and work effectively with minimal supervision. Capability to interpret engineering drawings, specifications, tolerances, inspection procedures, and sampling plans. Familiarity with inspection tools such as pin gauges, micrometers, calipers, pressure gauges, rulers, and microscopes. Strong written and verbal communication skills. #J-18808-Ljbffr