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 integral 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 global 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 organizations across multiple sites or regions

Strong knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820, and MDSAP requirements

Demonstrated success partnering with senior operations leaders while supporting frontline quality teams

Experience with quality systems, ERP platforms such as SAP, and digital quality tools

Strong analytical, strategic thinking, and problem-solving skills

Excellent leadership, communication, stakeholder management, and influencing abilities

Experience with Lean, Six Sigma, workflow automation, data analytics, or AI-supported quality initiatives is a plus

Fluent English required
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!
What we offer:

• Benefits in accordance with the Federal Labor Law (LFT)
• Savings fund (Fondo de Ahorro)
How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

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