QMS Manager

About the role

EarSwitch Ltd. is developing breakthrough sensing and data technologies for next‑generation earphones, headsets and health devices. The QMS Manager will lead the design, implementation and maintenance of a robust Quality Management System that meets ISO 13485 certification requirements, ensuring safe, reliable and well‑documented processes across the organisation.

Key responsibilities

• Develop, implement and maintain EarSwitch’s Quality Management System (QMS) and associated Standard Operating Procedures (SOPs).
• Lead investigations of non‑conformances, process deviations and operational issues, driving root‑cause analysis and corrective‑preventive actions (CAPA).
• Support risk management activities, maintain risk registers and track mitigation actions.
• Ensure operational activities follow agreed processes, timelines and quality expectations.
• Coordinate project planning, workflow oversight and supplier collaboration.
• Prepare quality records, reports and operational documentation; present updates to stakeholders.
• Provide guidance and training to staff on quality procedures, document management and new workflows.

Required profile

• Proven experience managing a QMS in a regulated environment, preferably medical devices.
• Strong understanding of ISO 13485 standards and certification processes.
• Demonstrated ability to lead investigations, conduct root‑cause analysis and implement CAPA.
• Excellent communication skills to collaborate with internal teams and external partners.
• Organisational skills to manage documentation, risk registers and project coordination.

Required skills

• ISO 13485 compliance
• CAPA (Corrective and Preventive Action) management
• Risk management and risk register maintenance
• Document control and SOP development