Senior Manager, Design Quality Assurance

About the Role Lead the Design Quality Assurance team in Singapore to ensure that medical devices are safe, effective, and launched in alignment with Sonova's design control requirements and protocols. This leadership role covers hardware and software development and ongoing post-launch reliability activities. What You'll Do

• Lead the Design Quality Assurance team, assign members to project teams, and ensure products are launched per plan with minimal process deviations.
• Act as the quality representative for design and development activities of medical devices (hardware and software), and participate directly in development projects.
• Coach team members and support career development; ensure effective execution and documentation of Post-Launch Engineering activities.
• Communicate project progress to the Department Manager and collaborate with stakeholders across the organization.
• Harmonize procedures and processes within R&D to eliminate redundancies and standardize where feasible.
• Support product improvements, particularly reliability (e.g., FMEAs); ensure SOPs align with internal and external regulations.
• Support Process Owners with SOP creation/maintenance, drive process improvements, and assist with open CAPAs, Post Launch Changes, and NCs as required. What We're Looking For
• Education: Bachelor's degree in engineering, science, or quality with 10+ years of experience (or Master's with 8+ years).
• Regulatory Knowledge: In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, MDR 2017/745; familiarity with QMSR, MDSAP, ISO 9001, IEC 62366-1, EU AI Act is a plus.
• Experience: 10+ years in regulated environment, preferably Medical Devices; proven quality leadership in large, multi-site global orgs.
• Technical Skills: Practical experience with Design Control, Product Risk Management, and Medical Device Development (including SaMD); understanding AI functionality and risks in medical devices.
• Personal Attributes: Self-confident, well-organized, reliable, strong stakeholder management; ability to explain complex device quality regulations to non-experts.
• Leadership: Experience leading teams toward challenging but achievable goals; committed to developing and motivating people.
• Language & IT: Professional English; German is a plus. Advanced MS Office; Polarion and SAP beneficial. Nice to Have
• German language skills are a nice-to-have. Compensation & Benefits
• Flexible hybrid working model; opportunity to balance career with personal commitments.
• Training opportunities and individual development plans; growth opportunities.
• Inclusive culture; equal opportunity employer; diverse teams.