Quality System Manager

Quality System ManagerLocation: Remote (Europe-based preferred)Type: Full-timeIndustry: Digital Health, SaMD, DTxReports to: Head of CompliancePosition OverviewWe 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 HealthShape the next generation of digital health solutions.Work in a certified SaMD environment at the forefront of behavioral science and AI.Collaborate with leading partners in Pharma, MedTech, and academic research.Enjoy a remote-first culture, supported by cross-disciplinary teams passionate about patient outcomes.Be part of an organization building scalable, evidence-based impact in chronic care management.Originally posted on Himalayas