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.
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