Director, QA Operations Americas
Mexicali, BC, México – Onsite

The Director, QA Operations Americas provides strategic and operational leadership for Quality Assurance teams across the Americas, ensuring regional quality activities align with Sonova’s global Quality Management System and applicable medical device regulations. This role serves as the key liaison between Global Quality and regional Operations, driving compliance, operational excellence, and continuous improvement while building strong partnerships with senior leaders and local quality teams.

Responsibilities:

Lead, coach, and develop regional QA teams across the Americas, building a high-performing quality organization
Partner with senior operations leaders to align quality priorities and mitigate operational risks
Work closely with local quality teams to resolve issues and ensure consistent execution of general quality processes
Ensure compliance with Sonova’s Quality Management System and applicable regulations including ISO 13485, EU MDR, FDA 21 CFR Part 820, and MDSAP




Maintain inspection readiness and support internal and external regulatory audits
Oversee key Quality Management System processes including CAPA, nonconformance, change control, and document control
Monitor quality KPIs, identify trends, perform root cause analysis, and implement corrective actions
Collaborate with Regulatory Affairs, Supplier Quality, Manufacturing Engineering, and Commercial teams to drive quality improvements
Support initiatives that reduce rework, scrap, and cost of poor quality while improving operational performance
Promote a strong culture of quality, compliance, accountability, and continuous improvement throughout the region

More about you:

Bachelor's degree in Engineering, Life Sciences, Quality, or another relevant technical discipline required; Master's degree preferred
10+ years of quality leadership experience within a regulated medical device manufacturing environment
Experience leading quality org

📌 Director QA OPS Americas (Mexicali)
🏢 Sonova
📍 Mexicali