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Full-time
bachelor degree, postgraduate degree
Benefits in accordance with the Federal Labor Law (LFT), Savings fund
Posted 9d ago
~40 hrs/week
Responsibilities
The Director, QA Operations Americas leads and develops regional QA teams, ensuring alignment with global quality standards and regulations. This role also involves partnering with senior operations leaders to mitigate risks and drive continuous improvement.
Requirements
Candidates must have a bachelor's degree in a relevant field and at least 10 years of quality leadership experience in a regulated medical device environment. Strong knowledge of quality systems and regulatory requirements is essential.
Full job description
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 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.
Related keywords
Quality AssuranceLeadershipRegulatory ComplianceISO 13485EU MDRFDA 21 CFR Part 820MDSAPCAPANonconformanceChange ControlDocument ControlQuality KPIsRoot Cause AnalysisCorrective ActionsLeanSix Sigma
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From personal audio devices and wireless communication systems to audiological care services, hearing aids, and cochlear implants. Our product brands – Phonak, Unitron, Sennheiser (under license), and Advanced Bionics – create compelling new products to offer the optimal solution for an ever growing consumer base through our globally diversified sales and distribution channels, including our well established global audiological care business. With a presence in over 100 countries and more than 19,000 employees, we leverage our global infrastructure and local roots. We aim for an inclusive work environment and culture that fosters a good balance of family and work-life for everyone. Our workforce is made up of 110 nationalities across 4 generations.
In 2006, Sonova founded the non-profit Hear the World Foundation, which seeks to give children living with hearing loss access to audiological care in low- to middle-income countries.
Offices: Laubisrütistrasse 28, Stäfa, 8712, CH
Information TechnologyWearablesMedical DeviceCommunication HardwareWirelessCustomer ServiceConsumer ElectronicsManufacturing
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From personal audio devices and wireless communication systems to audiological care services, hearing aids, and cochlear implants. Our product brands – Phonak, Unitron, Sennheiser (under license), and Advanced Bionics – create compelling new products to offer the optimal solution for an ever growing consumer base through our globally diversified sales and distribution channels, including our well established global audiological care business. With a presence in over 100 countries and more than 19,000 employees, we leverage our global infrastructure and local roots. We aim for an inclusive work environment and culture that fosters a good balance of family and work-life for everyone. Our workforce is made up of 110 nationalities across 4 generations.
In 2006, Sonova founded the non-profit Hear the World Foundation, which seeks to give children living with hearing loss access to audiological care in low- to middle-income countries.
Offices: Laubisrütistrasse 28, Stäfa, 8712, CH
Information TechnologyWearablesMedical DeviceCommunication HardwareWirelessCustomer ServiceConsumer ElectronicsManufacturing