Quality Manager

vor 1 Tag

Home Office, Schweiz Aeon Vollzeit

At Aeon, we’re reinventing preventive healthcare by empowering individuals to take charge of their health. By combining whole-body MRI scans, blood tests, and AI-driven insights, we help our customers live longer, healthier, and more fulfilling lives. Our vision is to make proactive health assessments accessible, insightful, and actionable for everyone.
As we grow, so do our quality standards in our daily operations as well as in our medical product development. Therefore, we are looking for a Quality Manager to set up the foundations of an effective Quality Management System with us.
Tasks
- Lead the initial setup of our Quality Management System (QMS) using Greenlight Guru.
- Define and implement processes to ensure quality across:
1. Daily medical operations, both internal and with partner practices.
2. Development of Software as a Medical Device (SaMD), starting with body composition quantification and extending to health risk modelling with machine learning.
- Train the Aeon team on QMS processes to ensure long-term self-sufficiency.
- Prepare all required documentation and establish workflows for compliance with relevant regulatory standards (e.g., ISO 13485 and MDR).
- Collaborate with medical, technical, and operations teams to embed quality practices seamlessly.

**Requirements**:

- ~5 years of experience in quality management, ideally in healthcare, digital health, or SaMD.
- Proven track record in startup environments or similar fast-paced settings.
- Familiarity with machine learning models as medical devices is a strong plus.
- Hands-on experience with QMS platforms, preferably Greenlight Guru.
- Strong knowledge of relevant regulations and standards (ISO 13485, MDR, AI Act).
- Excellent communication and training skills to enable a smooth handover to the internal team.
- Available for a 50% commitment (part-time) for an initial 3-month limited contract.
- Fully remote work possible.

**Benefits**:

- Opportunity to shape the foundation of Aeon’s quality management system from the ground up.
- Work at the intersection of healthcare, technology, and machine learning, with real-world impact on preventative medicine.
- Flexibility: part-time contract (50%), remote-friendly.
- Collaborate with a passionate, interdisciplinary team.

If you are excited about building high-quality systems in healthcare innovation and want to make a meaningful impact, we’d love to hear from you.

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