Aeon is hiring a Quality Manager (Part-Time, Limited Contract)

Aeon is looking for a part-time Quality Manager for an initial 3-month limited contract. You will be the architect of our foundational Quality Management System (QMS), building it from the ground up using Greenlight Guru. In this role, you'll establish the quality framework for our daily medical operations and our development of Software as a Medical Device (SaMD), while training our small team for long-term ownership.

What You'll Do

• Lead the initial setup and configuration of our Quality Management System (QMS) using Greenlight Guru.
• Define and implement quality processes for daily medical operations, including work with internal and partner practices.
• Define and implement quality processes for Software as a Medical Device (SaMD) development, starting with body composition tools and extending to machine learning-powered health risk models.
• Train and enable the Aeon team on QMS processes to ensure long-term self-sufficiency and compliance.
• Prepare required documentation and establish workflows to meet regulatory standards like ISO 13485 and MDR.
• Collaborate closely with medical, technical, and operations teams to integrate quality practices.

What We're Looking For

• Approximately 5 years of experience in quality management, ideally in healthcare, digital health, or SaMD.
• A proven track record of working in startup environments or similarly fast-paced settings.
• Hands-on experience with QMS platforms, with a strong preference for Greenlight Guru.
• Strong knowledge of relevant regulations and standards, such as ISO 13485, MDR, and the AI Act.
• Excellent communication and training skills to ensure a smooth, effective handover to the internal team.
• Availability for a 50% part-time commitment for the initial 3-month contract term.

Nice to Have

• Familiarity with machine learning models developed as medical devices.

Technical Stack

• QMS Platform: Greenlight Guru

Team & Environment

You'll be joining a compact, interdisciplinary team of 1-10 employees. You will collaborate directly with our medical, technical, and operations teams to embed quality into our core workflows.

Benefits & Compensation

• 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: This is a part-time contract (50%) and is remote-friendly.
• Collaborate with a passionate, interdisciplinary team.

Work Mode

This is a remote-friendly, global position.

Aeon is an equal opportunity employer.