Senior Quality Manager, Tijuana (Regulatory & Molding Experience)

Senior Quality Manager leading Tijuana operations' quality management system and manufacturing compliance. This on-site leadership role oversees quality team performance, regulatory audits, corrective actions, and shop floor quality support while driving continuous improvement across manufacturing operations.

Responsibilities

• Lead site quality management system and oversee CAPA, complaints, nonconformances, and change control processes
• Maintain visible presence on manufacturing floor to support operations and resolve quality issues
• Coordinate internal, customer, and regulatory audit preparation and compliance readiness
• Monitor quality performance metrics and drive corrective actions for systemic trends and recurring issues
• Lead continuous improvement initiatives to enhance product quality, process capability, and operational efficiency

Requirements

• Leadership experience managing quality teams and quality management systems
• Knowledge of GMP regulations and quality compliance standards
• Experience with CAPA, audits, nonconformances, and quality system processes
• Demonstrated ability to manage manufacturing quality issues and root cause analysis
• Strong data analysis and quality metrics/KPI tracking skills
• Fluency in Spanish and English preferred for Tijuana operations