Quality System Manager
newelhealth· Operations
About this role
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.
Frequently Asked Questions
Is the salary disclosed for the Quality System Manager position at newelhealth?
The salary for this Quality System Manager role at newelhealth is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Quality System Manager job at newelhealth remote?
Yes, this Quality System Manager position at newelhealth is remote, with team members based in Remote. You can work from home or anywhere in the supported regions.
Is the Quality System Manager role at newelhealth full-time or part-time?
This is listed as a Permanent position. It is posted as a Quality System Manager role in the Operations department at newelhealth.
Which team or department does the Quality System Manager at newelhealth belong to?
This Quality System Manager position is part of the Operations department at newelhealth. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Quality System Manager position at newelhealth?
Click the "Apply Now" button on this page. You will be redirected to newelhealth's official application portal hosted on bamboohr where you can submit your application directly.
When was the Quality System Manager job at newelhealth posted?
This Quality System Manager position at newelhealth was posted on May 7, 2025. Apply as soon as possible — early applications are often reviewed first.
Quality System Manager
newelhealth
You'll be redirected to newelhealth's official application page on bamboohr.