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 operations.

4. Training & Quality Culture

Train teams on QMS requirements and compliance processes. Drive organization-wide quality awareness.

Preferred Profile

6–12+ years in QMS / Quality Assurance Hands-on experience in ISO 13485 implementation Experience handling external audits Background in medical device manufacturing preferred Strong process and documentation mindset