Senior Manager Design Quality Assurance

About the role

Sonova is seeking a Senior Manager to lead its Design Quality Assurance team in Singapore. The role ensures that new and existing medical device products meet the highest safety, effectiveness, and regulatory standards throughout their lifecycle.

Key responsibilities

• Lead the Design Quality Assurance team, assigning members to projects and minimizing process deviations.
• Act as the quality representative for hardware and software development activities, participating directly in projects.
• Coach team members, support career development, and oversee post‑launch engineering documentation.
• Communicate project progress to the Department Manager and collaborate with cross‑functional stakeholders.
• Standardize R&D procedures, eliminate redundancies, and harmonize processes across the organization.
• Support product reliability improvements, including FMEA analysis, and ensure SOPs align with internal and external regulations.
• Assist Process Owners with SOP creation, process improvements, CAPA handling, post‑launch changes, and non‑conformities.

Required profile

• Bachelor’s degree in engineering, science, or quality (10+ years experience) or Master’s degree (8+ years experience).
• Extensive experience in a regulated medical‑device environment.
• Proven track record in quality roles driving product compliance and reliability.

Required skills

• ISO 13485
• ISO 14971
• IEC 62304
• MDR 2017/745
• QMSR
• MDSAP
• ISO 9001
• IEC 62366-1
• EU AI Act (knowledge)
• FMEA
• CAPA management
• SOP development and maintenance