Quality System Manager

Quality System Manager

Location: Remote (Europe-based preferred)

Type: Full-time

Industry: Digital Health, SaMD, DTx

Reports to: Head of Compliance

Position Overview

We are seeking a Quality System Manager to strengthen our ISO 13485-compliant Quality Management System. You will support internal audits, CAPAs, supplier evaluations, and documentation processes that underpin our medical-grade digital therapeutics. This role is key to our ability to maintain compliance while scaling agile and user-centered innovation across multiple therapeutic areas.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Why Join Newel Health