Director QA OPS Americas

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 Sonovas 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 global quality processes
• Ensure compliance with Sonovas 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:

• Bachelors degree in Engineering Life Sciences Quality or another relevant technical discipline required; Masters 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

Dont meet all the criteria If youre willing to go all in and learn wed 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.