Quality Engineer

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 :