Head of Quality

About the Company

Eyebot is an outcome-focused technology company on a mission to make vision care accessible to everyone, equally. Headquartered in Boston’s North End and backed by top investors and the National Science Foundation, our vision test kiosk is reshaping how vision care is delivered.

Responsibilities

• Build and lead Eyebot's quality management system, establishing SOPs, CAPA, document control, and supplier quality processes meeting FDA and ISO 13485 requirements
• Own the QA function including complaint handling, nonconforming product processes, incoming inspection, and production controls
• Embed design controls and risk management into the product development process
• Own internal audits and inspection readiness
• Serve as the quality counterpart to the regulatory function for domestic and international compliance milestones

Requirements

• Hands-on experience building or substantially rebuilding a QMS
• Deep ISO 13485 fluency
• Practical experience with design controls, risk management (ISO 14971), CAPA, and document control
• QA ownership experience in complaint handling, nonconforming product management, and production controls
• Experience with FDA quality system requirements (21 CFR Part 820 / QSR)
• Inspection readiness experience including internal audits, FDA, or third-party inspections

Preferred Qualifications

• Experience in a startup or high-growth environment
• Supplier quality and supply chain auditing experience
• Familiarity with international regulatory frameworks like EU MDR
• Background with post-market surveillance data analysis and complaint trending
• Experience with ophthalmic, diagnostic, or capital equipment devices

Benefits

• Starting target salary in the range of $150k-$190k plus meaningful equity
• Flexible work schedule with unlimited PTO
• Full health, dental, and vision insurance
• Commuter support and wellness benefits