Sonova

2 weeks ago

Director QA OPS Americas (Mexicali, Mexico)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Lead strategic and operational Quality Assurance across the Americas, ensuring regional activities align with the global Quality Management System and medical device regulations. Partner with Global Quality and regional Operations to drive compliance, inspection readiness, and operational excellence. Oversee core QA processes such as CAPA, nonconformance, change control, and document control, monitor quality KPIs, and collaborate with cross-functional teams to improve quality outcomes and reduce rework, scrap, and cost of poor quality.

Location: Mexico

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Director level

Key Responsibilities

•Provide strategic and operational leadership for QA teams across the Americas, aligning regional quality activities with the global Quality Management System.
•Partner with senior operations leaders to align quality priorities and mitigate operational risks.
•Oversee Quality Management System processes including CAPA, nonconformance, change control, and document control.
•Maintain inspection readiness and support internal and external regulatory audits.
•Monitor quality KPIs, perform root cause analysis, implement corrective actions, and collaborate with cross-functional teams to drive quality improvements.

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline; Master’s degree preferred.
•10+ years of quality leadership experience in regulated medical device manufacturing.
•Experience leading quality organizations across multiple sites or regions.
•Strong knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820, and MDSAP requirements.
•Fluent English; demonstrated leadership, communication, stakeholder management, and influencing abilities.

Experience:10+ yearsRegulated medical device manufacturing

Education:Bachelor's in Engineering, Life Sciences, Quality (or related technical discipline)

Skills:LeadershipCommunicationStakeholder managementInfluencingProblem-solving

Languages:English

Tech Stack:SAP

Company Brief

Sonova

Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website

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Sonova

2 weeks ago

Director QA OPS Americas (Mexicali, Mexico)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: Mexico

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Director level

Key Responsibilities

•Provide strategic and operational leadership for QA teams across the Americas, aligning regional quality activities with the global Quality Management System.
•Partner with senior operations leaders to align quality priorities and mitigate operational risks.
•Oversee Quality Management System processes including CAPA, nonconformance, change control, and document control.
•Maintain inspection readiness and support internal and external regulatory audits.
•Monitor quality KPIs, perform root cause analysis, implement corrective actions, and collaborate with cross-functional teams to drive quality improvements.

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline; Master’s degree preferred.
•10+ years of quality leadership experience in regulated medical device manufacturing.
•Experience leading quality organizations across multiple sites or regions.
•Strong knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820, and MDSAP requirements.
•Fluent English; demonstrated leadership, communication, stakeholder management, and influencing abilities.

Experience:10+ yearsRegulated medical device manufacturing

Education:Bachelor's in Engineering, Life Sciences, Quality (or related technical discipline)

Skills:LeadershipCommunicationStakeholder managementInfluencingProblem-solving

Languages:English

Tech Stack:SAP

Company Brief

Sonova

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website