Senior Director Quality Operations

This senior director role leads quality operations across two manufacturing and development sites for a diagnostics company. Responsibilities include driving regulatory compliance, building quality culture, managing multi-disciplinary teams, and deploying continuous improvement systems while partnering across operations, R&D, and supply chain functions.

Responsibilities

• Provide strategic quality leadership for Chaska and Carlsbad manufacturing sites
• Lead multi-disciplinary quality organization including QA, QC, process validation, design quality
• Ensure compliance with quality management systems and applicable regulatory requirements
• Manage site quality performance metrics and drive problem-solving for gaps
• Build, develop, and mentor diverse quality teams and leaders across organization

Requirements

• Bachelor's degree in scientific or engineering discipline with 20+ years experience, or advanced degree with 18+ years
• 6+ years of people leadership experience
• 10+ years quality leadership in in-vitro diagnostics or medical devices
• Multi-site or complex manufacturing environment leadership experience
• Deep knowledge of quality assurance, control, process validation, design quality
• Strong understanding of FDA, ISO, and global regulatory frameworks
• Proven structured problem-solving and data-driven decision-making abilities