Quality Assurance Manager

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UpDoc

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

🤖 Inteligência Artificial

☁️ SaaS

💰 Seed em 2024-02

Healthcare • Artificial Intelligence • SaaS

A UpDoc é uma empresa de IA clínica que oferece uma plataforma de software de nível empresarial, governada por médicos, integrada com prontuários eletrônicos (EHRs) e fluxos de trabalho clínicos para fornecer intervenções contínuas e baseadas em evidências entre consultas para o gerenciamento de doenças crônicas. A empresa enfatiza capacidades de modelo de linguagem de grande porte (LLM) voltadas para pacientes, aprovadas pela FDA, monitoramento de dados estruturados de pacientes, coordenação com equipes de cuidado, e integração operacional em sistemas de saúde para melhorar resultados, adesão e reduzir custos. A UpDoc conta com o apoio de organizações de saúde e parceiros farmacêuticos e de defesa, como a Clínica Mayo, Eli Lilly e a Associação Americana de Diabetes.

Descrição

• 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

🎯 Requisitos

• 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