Senior Manager, Digital Quality Excellence

Job Summary

Driving the enterprise digital quality strategy, the full-time Senior Manager, Digital Quality Excellence will lead the establishment of digital quality frameworks and analytics capabilities to enhance regulatory compliance and operational excellence in a remote capacity.

Key responsibilities

• Define and execute the Digital Quality Excellence strategy, ensuring compliance with regulatory requirements and alignment with organizational objectives
• Drive digital transformation and operational excellence by leveraging automation, AI, and analytics to improve quality processes and business productivity
• Develop governance frameworks for AI-enabled medical technologies, ensuring compliance and effective integration across product development and quality systems

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Data Science, or a related technical discipline; advanced degree preferred
• Minimum of 8 years of experience in Quality Systems, Quality Engineering, or related roles within regulated industries
• At least 5 years of leadership experience managing teams and enterprise-level initiatives
• Strong knowledge of global Quality Management System requirements, including FDA and ISO standards
• Experience with AI, machine learning, or advanced analytics in regulated environments