Manager – Quality & Compliance (ISO 13485)

Description
The Quality & Compliance Lead is responsible for establishing, maintaining, and improving Taevas’ Quality Management System (ISO 13485) and ensuring compliance with global regulatory standards.
This role ensures that all processes, documentation, and operations meet audit, certification, and regulatory expectations.

Key Responsibilities
1. ISO 13485 QMS Implementation
Lead end-to-end implementation of ISO 13485.
Develop and maintain SOPs, quality manuals, and process documentation.
Ensure alignment across departments (Regulatory, Supply Chain, Service Delivery).
2. Audit & Compliance Management
Plan and conduct internal audits.
Prepare for external audits and certification processes.
Address non-conformities through CAPA.
3. Quality Systems & Processes
Establish CAPA, change control, deviation management, and risk management (ISO 14971).
Maintain documentation control systems.
Ensure process standardization across global op...