Quality Engineer 1
Current• Serves as a Quality representative, ensuring compliance with Acumed policies and global regulations in design control, verification, validation, risk management, and specification development for new product development teams.• Collaborates with cross-functional project teams (Acutrak 3 and Radial Head Spacer), providing expertise to ensure adherence to regulations, procedures, and requirements throughout the product life cycle.• Implement data collection and analysis techniques to assess product reliability and performance, contributing to the design and development of high-quality products.• Ensures the quality and completeness of design history files, engineering change orders, and supports ongoing quality engineering activities, including CAPA investigations and risk management.• Collaborate with cross-functional teams to conduct root cause analysis for non-conformities and implement corrective and preventive actions (CAPA).• Drives product risk management activities, ensuring the execution of identified mitigations and actively participating in technical discussions using a risk-based approach.• Reviews and enhances cGMP compliance by analyzing verification and validation protocols, identifying gaps, and recommending efficient strategies for closure.