Quality System Manager

Role Overview

• Maintain and improve our QMS in alignment with ISO 13485, MDR, and applicable FDA regulations.
• Support internal and supplier audits, prepare documentation, and lead follow-up activities.
• Manage CAPAs, nonconformities, and change control documentation.
• Provide QA oversight to product development activities, including design controls and verification/validation protocols.
• Train internal teams on quality procedures and support audit readiness across functions.

Requirements

• 3+ years of quality assurance experience in medical devices or health tech.
• Solid understanding of ISO 13485, ISO 14971, IEC 62304, IEC 62366 and MDR compliance.
• Strong documentation and organizational skills.
• Excellent English communication skills.

Benefits

• Remote-first culture
• Collaboration with cross-disciplinary teams