Sonova

2 weeks ago

Senior Manager Design Quality Assurance

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Lead the Design Quality Assurance team in Singapore, ensuring medical device hardware and software are launched according to Sonova design control requirements and procedures. Act as quality representative across design and development work, coach and develop team members, and drive Post-Launch Engineering execution and documentation. Harmonize R&D processes, support reliability activities (including FMEAs), and help manage CAPAs, Post Launch Changes, and NCs while communicating status to department leadership and stakeholders.

Location: Singapore

Workplace: Hybrid

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Manager level

Key Responsibilities

•Direct and guide the Design Quality Assurance team in Singapore, assigning members to projects and minimizing process deviations during product launches.
•Serve as the quality representative for design and development activities for medical devices (hardware and software) and participate in development projects.
•Coach team members and support career development, ensuring effective execution and documentation of Post-Launch Engineering activities.
•Communicate project progress and status to the Department Manager and collaborate with relevant stakeholders.
•Establish and align procedures across R&D, support reliability improvements (e.g., FMEAs), and assist with SOP management, CAPAs, Post Launch Changes, and NCs as required.

Key Requirements

•Bachelor’s degree in engineering, science, or quality with 10+ years of relevant work experience (or a Master’s with 8+ years).
•In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, and MDR 2017/745 (plus familiarity with QMSR, MDSAP, ISO 9001, IEC 62366-1, and the EU AI Act).
•Over a decade of experience in a regulated environment, preferably Medical Devices, with increasing responsibility in Quality roles.
•Practical experience with Design Control, Product Risk Management, and Medical Device Development including software (e.g., SaMD), plus understanding AI functionality risks.
•Professional proficiency in English (written and spoken) and advanced MS Office; Polarion and SAP experience are beneficial.

Experience:10+ yearsMedical devicesRegulated environmentQuality assurance

Education:Bachelor's

Skills:LeadershipStakeholder managementCommunicationOrganizational skillsCoaching

Languages:EnglishGerman

Tech Stack:ISO 13485ISO 14971IEC 62304MDR 2017/745QMSRMDSAPISO 9001IEC 62366-1EU AI ActSaMDDesign ControlProduct Risk ManagementFMEACAPASOPPolarionSAPMS OfficeR&D

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

Senior Manager Design Quality Assurance

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Location: Singapore

Workplace: Hybrid

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Manager level

Key Responsibilities

•Direct and guide the Design Quality Assurance team in Singapore, assigning members to projects and minimizing process deviations during product launches.
•Serve as the quality representative for design and development activities for medical devices (hardware and software) and participate in development projects.
•Coach team members and support career development, ensuring effective execution and documentation of Post-Launch Engineering activities.
•Communicate project progress and status to the Department Manager and collaborate with relevant stakeholders.
•Establish and align procedures across R&D, support reliability improvements (e.g., FMEAs), and assist with SOP management, CAPAs, Post Launch Changes, and NCs as required.

Key Requirements

•Bachelor’s degree in engineering, science, or quality with 10+ years of relevant work experience (or a Master’s with 8+ years).
•In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, and MDR 2017/745 (plus familiarity with QMSR, MDSAP, ISO 9001, IEC 62366-1, and the EU AI Act).
•Over a decade of experience in a regulated environment, preferably Medical Devices, with increasing responsibility in Quality roles.
•Practical experience with Design Control, Product Risk Management, and Medical Device Development including software (e.g., SaMD), plus understanding AI functionality risks.
•Professional proficiency in English (written and spoken) and advanced MS Office; Polarion and SAP experience are beneficial.

Experience:10+ yearsMedical devicesRegulated environmentQuality assurance

Education:Bachelor's

Skills:LeadershipStakeholder managementCommunicationOrganizational skillsCoaching

Languages:EnglishGerman

Tech Stack:ISO 13485ISO 14971IEC 62304MDR 2017/745QMSRMDSAPISO 9001IEC 62366-1EU AI ActSaMDDesign ControlProduct Risk ManagementFMEACAPASOPPolarionSAPMS OfficeR&D

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