Medical Device Quality Systems Manager

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 contr...