Head Of/director Quality Management Juarez (Ciudad Juárez)

City: Juárez, Chihuahua, Mexico State: Mexico Country: Mexico Business Area: Quality Assurance Department: Global Quality Management Employment Type: Full-time Req ID: 9644

Location: Juarez, Mexico

Reports to: VP, Global Quality Management

Company: Ambu

Key Responsibilities

• Act as Site Quality Management Representative and designated Management Representative.
• Oversee and ensure the effective establishment, implementation, and maintenance of the Quality Management System (QMS) in accordance with FDA, ISO, and other applicable standards.
• Lead the final release of Ambu A/S and King System products, with authority to stop manufacturing, shipments, and deliveries if quality is at risk.
• Initiate recalls, CAPAs (Corrective and Preventive Actions), and NCRs (Nonconformance Reports) as needed.
• Approve or reject change requests, vali...