Teams at Carlsmed

Manages quality systems for medical device products, including CAPA, audits, change control, documentation, field actions, regulatory compliance, and quality metrics. Leads root cause analysis, corrective action planning, audit scheduling and execution, regulatory audit support, standards gap assessments, process improvement projects, and quarterly quality trend reporting. Requires medical device quality assurance experience, lead auditing, regulatory standards knowledge, advanced Excel and PowerPoint skills, and strong technical communication.

Provide organization-wide technical leadership for Carlsmed’s personalized spine surgery software platform. Define platform architecture, technical vision, standards, governance, and technology strategy. Guide Node.js microservices, GraphQL federation, React applications, PostgreSQL solutions, APIs, distributed systems, and proof-of-concept initiatives. Mitigate technical risks, lead major architectural decisions, collaborate with senior leadership, and mentor senior engineers and technical leads.

Oversee and improve IT systems, infrastructure, and services while supporting reliable, secure, and efficient operations. Implement IT strategy, enforce policies and compliance with HIPAA and FDA requirements, conduct audits and security assessments, coordinate IT projects, resolve business application disruptions, and maintain service desk and operational documentation.