Author and QA AI-driven automations for defined healthcare workflows, execute accurate high-volume automation tasks, provide support, and maintain technical and process documentation. Collaborate remotely with product, engineering, and QA teams using GitHub, Slack, and JIRA while contributing to application and developer-tooling improvements. This is a three-month remote contract requiring rapid ramp-up, strong communication, software engineering fundamentals, and exceptional attention to detail.

Leads the company’s quality management and regulatory compliance programs for medical-device manufacturing. Maintains ISO 13485 and FDA 21 CFR Part 820 compliance, oversees audits, CAPAs, validations, supplier approvals, gage control, sterilization and packaging requirements, and continuous process improvement. Manages quality personnel, supports training and performance management, develops customer and supplier relationships, and reports quality-system effectiveness to executive leadership. The role also participates in material review, cost reduction, and manufacturing process optimization.