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

• Shape 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.