Sonova

13 hours ago

Manager Global QMS

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

Lead and continuously improve Sonova’s global Quality Management System (QMS) across regions and functions. Drive consistent execution of core QMS processes including CAPA, non-conformities, document and change control, audits, training, and management review. Use quality metrics to identify improvement opportunities, harmonize processes with global/regional quality teams, and support regulatory inspections and internal audits through strong readiness and effective CAPA follow-up.

Location: Warsaw

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Implement, maintain, and continuously improve Sonova’s global QMS while aligning with regulatory requirements and business objectives.
•Drive consistent execution of core QMS processes including CAPA, non-conformities, document control, change control, audits, training, and management review.
•Monitor QMS performance through quality metrics and support initiatives that enhance compliance and operational effectiveness.
•Collaborate with global process owners and regional quality teams to harmonize processes and ensure consistent implementation.
•Support regulatory inspections and internal audits by ensuring inspection readiness, accurate documentation, and follow-up of corrective and preventive actions.

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, Quality Management or related discipline (Master’s degree advantageous).
•At least 5 years’ Quality experience in a regulated industry, ideally medical devices, with experience supporting or managing global QMS.
•Strong knowledge of international quality and regulatory standards including ISO 13485, MDR/IVDR, FDA 21 CFR Part 820, GMP/GDP and MDSAP.
•Experience supporting regulatory inspections, quality governance, and continuous improvement across global organizations.
•Internal Auditor or other Quality Management certifications and fluent English (German or Spanish advantageous).

Experience:5+ yearsMedical devicesRegulated industryGlobal operations

Education:Bachelor's in Engineering, Life Sciences, Quality Management

Skills:AnalyticalProblem-solvingOrganizationalStakeholder managementCommunication

Certifications:Internal AuditorQuality Management certifications

Languages:EnglishGermanSpanish

Tech Stack:CAPAISO 13485MDRIVDRFDA 21 CFR Part 820GMPGDPMDSAPDocument controlChange controlQuality metricsManagement reviewNon-conformitiesAuditsInternal auditsRegulatory inspections

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

13 hours ago

Manager Global QMS

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

Location: Warsaw

Workplace: Hybrid

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Implement, maintain, and continuously improve Sonova’s global QMS while aligning with regulatory requirements and business objectives.
•Drive consistent execution of core QMS processes including CAPA, non-conformities, document control, change control, audits, training, and management review.
•Monitor QMS performance through quality metrics and support initiatives that enhance compliance and operational effectiveness.
•Collaborate with global process owners and regional quality teams to harmonize processes and ensure consistent implementation.
•Support regulatory inspections and internal audits by ensuring inspection readiness, accurate documentation, and follow-up of corrective and preventive actions.

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, Quality Management or related discipline (Master’s degree advantageous).
•At least 5 years’ Quality experience in a regulated industry, ideally medical devices, with experience supporting or managing global QMS.
•Strong knowledge of international quality and regulatory standards including ISO 13485, MDR/IVDR, FDA 21 CFR Part 820, GMP/GDP and MDSAP.
•Experience supporting regulatory inspections, quality governance, and continuous improvement across global organizations.
•Internal Auditor or other Quality Management certifications and fluent English (German or Spanish advantageous).

Experience:5+ yearsMedical devicesRegulated industryGlobal operations

Education:Bachelor's in Engineering, Life Sciences, Quality Management

Skills:AnalyticalProblem-solvingOrganizationalStakeholder managementCommunication

Certifications:Internal AuditorQuality Management certifications

Languages:EnglishGermanSpanish

Tech Stack:CAPAISO 13485MDRIVDRFDA 21 CFR Part 820GMPGDPMDSAPDocument controlChange controlQuality metricsManagement reviewNon-conformitiesAuditsInternal auditsRegulatory inspections

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