Head of Quality

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.

If you are passionate about solving big problems and building the future of vision care, we would love to hear from you.

We are looking for a Head of Quality to build and lead Eyebot's quality and quality assurance function as we scale our medical device operations across the United States and into international markets. This is a systems-building role: you will establish and own the QMS, embed design controls and risk management into how our engineering team works, and build the QA processes - complaint handling, nonconformance management, incoming inspection, and production controls - that sustain product quality as we grow. You will work closely with engineering, operations, and our regulatory lead, and you will be the person the team turns to when they have a quality or compliance question.

Note: This is a full-time, onsite role based in Boston's Charlestown neighborhood. We work together five days a week to support rapid prototyping and cross-functional collaboration.

Build and lead Eyebot's quality management system - establishing SOPs, CAPA, document control, and supplier quality processes that meet FDA and ISO 13485 requirements. Own the QA function: stand up complaint handling and nonconforming product processes, establish incoming inspection and production controls, and manage the quality-side inputs that feed post-market surveillance. Embed design controls and risk management into the product development process in a way that engineers actually engage with. Own internal audits and inspection readiness, and serve as the quality counterpart to Eyebot's regulatory function as we pursue domestic and international compliance milestones.

• Hands-on experience building or substantially rebuilding a QMS - not just maintaining a mature system

• Deep ISO 13485 fluency; this is a baseline, not a differentiator

• Practical experience with design controls, risk management (ISO 14971), CAPA, and document control - embedded with engineering teams, not just as a reviewer

• QA ownership experience: complaint handling, nonconforming product management, incoming inspection, and production or process controls

• Experience with FDA quality system requirements (21 CFR Part 820 / QSR)

• Inspection readiness experience - internal audits, FDA, or third-party

• Experience in a startup or high-growth environment where you built processes from scratch

• Supplier quality and supply chain auditing experience

• Some familiarity with international regulatory frameworks, particularly EU MDR - enough to collaborate effectively with the regulatory function; PRRC experience is a plus but not required

• Background with post-market surveillance data analysis and complaint trending

• Experience with ophthalmic, diagnostic, or capital equipment devices

• You are energized by fast-paced environments and excited to grow with a startup that is scaling quickly.

• You take ownership of your work and care deeply about quality.

• You hold yourself and your teammates to a high bar.

• You follow through on commitments and take responsibility for outcomes.

• You bring a low ego, collaborative mindset. You are easy to work with, open to feedback, and able to keep perspective even when things don't go according to plan.