Systems Design Quality Engineer

Responsibilities

·  Manage Design Control, including design inputs, verification, validation, and design transfer. 

·  Develop and execute process and product validation strategies using statistical/data analysis. 

·  Create and maintain quality plans and technical documentation for hardware, software, and systems. 

·  Perform RCA, CAPA, FMEA, risk assessments, and defect investigations. 

·  Support Design Verification Planning (DVP) and Design Validation Planning. 

·  Evaluate product performance, reliability, manufacturability, usability, and safety. 

·  Use Post-Market Surveillance (PMS) data to identify quality issues and corrective actions. 

·  Support quality audits, regulatory compliance, and continuous improvement initiatives. 

·  Work closely with engineering, manufacturing, R&D, and other stakeholders.