Quality Assurance Manager

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UpDoc

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🤖 Artificial Intelligence

☁️ SaaS

💰 Seed on 2024-02

Healthcare • Artificial Intelligence • SaaS

UpDoc is a clinical AI company that provides an enterprise-grade, physician-governed software platform integrated with EHRs and clinical workflows to deliver continuous, evidence-based interventions between visits for chronic disease management. The company emphasizes FDA-cleared, patient-facing large language model (LLM) capabilities, monitoring structured patient data, coordinating with care teams, and operationally embedding into health systems to improve outcomes, adherence, and reduce costs. UpDoc is backed by healthcare organizations and pharmaceutical and advocacy partners (e. g. , Mayo Clinic, Eli Lilly, American Diabetes Association).

📋 Description

• Report to the Director of Quality Assurance and help build and scale UpDoc’s quality management system • 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 • Grow the quality function over time as the company scales

🎯 Requirements

• Strong communication skills and a track record of building a culture of quality from the ground up • 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, including 5+ years in an FDA-regulated environment • Software experience preferred • 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 such as ASQ or RAPS highly desired • ISO 13485 Auditor certification highly desired • Experience with Software as a Medical Device, including IEC 62304 and IEC 82304, highly desired • Experience in early-stage or high-growth startups and building QMS processes from scratch highly desired • Experience with HIPAA and SOC 2 regulated environments highly desired