Quality Engineer - Medical Devices & CAPA Lead

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• Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
• Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
• Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
• Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
• Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
• Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
• Ensure compliance with Quality Management Systems (QMS) and applicable re...