Mexicali, Mexico

Director, QA Operations Americas

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 integral 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

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.

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.

Sonova is an equal opportunity employer.

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