Senior Software Quality Assurance Engineer

The Senior Software Quality Assurance Engineer leads risk-based Computer Software Assurance and Computer System Validation activities to ensure confidence in software and digital systems supporting medical device contract manufacturing operations. This role serves as a primary Quality resource for the corporate electronic Quality Management System, partnering with cross-functional teams to ensure regulated systems are fit for intended use and maintained in a validated state. The position involves overseeing software assessments, providing quality oversight for system configurations, and collaborating with business and IT stakeholders to align system requirements with approved business processes.