Mexicali, MexicoDirector, QA Operations AmericasThe 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 Integral Quality and regional Operations, driving compliance, operational excellence, and continuous improvement while building strong partnerships with senior leaders and local quality teams.ResponsibilitiesLead, coach, and develop regional QA teams across the Americas, building a high-performing quality organizationPartner with senior operations leaders to align quality priorities and mitigate operational risksWork closely with local quality teams to resolve issues and ensure consistent execution of global quality processesEnsure compliance with Sonova's Quality Management System and applicable regulations including ISO *****, EU MDR, FDA 21 CFR Part 820, and MDSAPMaintain inspection readiness and support internal and external regulatory auditsOversee key Quality Management System processes including CAPA, nonconformance, change control, and document controlMonitor quality KPIs, identify trends, perform root cause analysis, and implement corrective actionsCollaborate with Regulatory Affairs, Supplier Quality, Manufacturing Engineering, and Commercial teams to drive quality improvementsSupport initiatives that reduce rework, scrap, and cost of poor quality while improving operational performancePromote a strong culture of quality, compliance, accountability,



and continuous improvement throughout the regionMore about youBachelor's degree in Engineering, Life Sciences, Quality, or another relevant technical discipline required; Master's degree preferred10+ years of quality leadership experience within a regulated medical device manufacturing environmentExperience leading quality organizations across multiple sites or regionsStrong knowledge of ISO *****, EU MDR, FDA 21 CFR Part 820, and MDSAP requirementsDemonstrated success partnering with senior operations leaders while supporting frontline quality teamsExperience with quality systems, ERP platforms such as SAP, and digital quality toolsStrong analytical, strategic thinking, and problem-solving skillsExcellent leadership, communication, stakeholder management, and influencing abilitiesExperience with Lean, Six Sigma, workflow automation, data analytics, or AI-supported quality initiatives is a plusA 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 offerBenefits in accordance with the Federal Labor Law (LFT)Savings fund (Fondo de Ahorro)How we workAt 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