Quality System Manager

Newel Health is seeking a dedicated Quality System Manager to strengthen our ISO 13485-compliant Quality Management System. You will play a pivotal role in supporting internal audits, managing CAPAs, and overseeing documentation processes that underpin our medical-grade digital therapeutics, ensuring we maintain compliance while scaling agile innovation.

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.

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.

What we offer

• 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.
• Be part of an organization building scalable, evidence-based impact in chronic care management.