Quality Assurance Manager – Lead QMS Development

About the role

Novir is seeking a Quality Assurance Manager to lead the continuous development and maintenance of its Quality Management System (QMS). The role ensures compliance with regulatory requirements such as ISO 13485, IVDR, and FDA, while driving product quality and risk assessment initiatives across the organization.

Key responsibilities

• Develop, implement, and maintain a robust QMS aligned with ISO 13485, IVDR, and FDA regulations.
• Oversee documentation, supplier qualification, internal audits, and corrective/preventive actions.
• Collaborate with cross‑functional teams to define product and process quality specifications.
• Lead continuous improvement projects to enhance product safety and customer satisfaction.
• Foster a culture of quality and continuous improvement throughout the company.

Required profile

• Strong analytical mindset with a process‑oriented approach.
• Strategic and collaborative leadership style.
• Meticulous attention to detail and proactive problem‑solving.
• Passion for delivering high‑quality medical diagnostic products.

Required skills

• In‑depth knowledge of ISO 13485.
• Experience with IVDR and FDA regulatory frameworks.
• Proficiency in Quality Management System (QMS) implementation.
• Risk assessment and mitigation expertise.
• Supplier qualification and audit management.