Quality Assurance Manager

About Up Doc

At UpDoc, we are building the first clinically validated, physician-supervised AI agents that manages chronic diseases. We are an early-stage startup founded by Stanford physicians.

We are seeking a talented and motivated QA Manager, reporting to the Director of Quality Assurance to join our team and help us build and scale our quality management system as we bring our AI-powered chronic disease platform to patients and providers.

This is a fully remote position.

You're an enthusiastic, self-motivated quality professional with strong communication skills and a track record of building a culture of quality from the ground up. You're comfortable being hands-on in a fast-paced startup environment, and excited to implement and grow a value-added QMS grounded in FDA and ISO 13485 requirements. This role has no direct reports today, but will grow the function over time as the company scales.

• Lead internal audits, gap assessments, and action item closure for periodic QMS reviews
• Manage and Maintain Design and Development Files for FDA regulated products.
• Manage Quality Training:
  Guide team members on quality system use, and follow up on training compliance and QMS action items
• Build and refine quality systems and SOPs in line with cGxP, ISO 13485, and other applicable standards
• Own and manage UpDoc’s NCR, CAPA, and post-market surveillance processes
• Administer, and maintain UpDoc's eQMS (Qualio)
• Collaborate across departments to follow through on change implementation action items
• Assist or provide support to the customer support team as needed

• Working knowledge of core QMS concepts and medical device standards, including 21 CFR 820, ISO 13485, and ISO 14971
• Experience implementing or improving quality processes at a medical device or digital health company
• 7+ years in a regulated medical device environment (software experience preferred), including 5+ years in an FDA-regulated environment
• Bachelor's degree in Computer Science, Life Sciences, Engineering, or equivalent experience
• Comfort with common software startup tools and platforms, such as Jira, Linear, Slack and Google Workspace

• Professional certification (ASQ, RAPS)
• ISO 13485 Auditor certification
• Experience with Software as a Medical Device (IEC 62304, IEC 82304)
• Experience in early-stage or high-growth startups, building QMS process from scratch
• Experience with HIPAA and SOC 2 regulated environments