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.
• Originally posted on Himalayas