Responsibilities: Lead customer complaint and CAPA investigations Manage ECOs, deviations, and documentation updates Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports. Analyze process and test method validation data. Manages activities for handling healthcare products from receiving to shipping. Assessing and ensuring compliance through training, auditing, and capa Participate in customer audits and provide input to any observations. Train personnel Make appropriate changes to fixtures or inspection methods and tools as required. Participate in design reviews Visit customers and suppliers Work with Engineering, Manufacturing and Tooling on continuous improvement activities Qualifications: Bachelor of Science Degree 5-7 years of experience as a Quality Engineering in the healthcare industry |
