Head of Quality

About the role

We are seeking a Head of Quality to lead Eyebot's quality and quality assurance function as we expand our medical device operations domestically and internationally. This role requires hands-on experience building or rebuilding a QMS, practical experience with design controls and risk management, and a strong background in FDA quality system requirements.

Responsibilities

• 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 actively 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.

Requirements

• 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

Qualifications

• 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

Skills

• Energetic and excited to grow with a startup that is scaling quickly
• Ownership of your work and a deep commitment to quality
• A low ego, collaborative mindset
• Easy to work with, open to feedback, and able to maintain perspective even when things don't go according to plan

Benefits

• Starting target salary in the range of $150k-$190k, along with meaningful equity
• A flexible work schedule with unlimited PTO
• A culture where every idea is welcome, no matter how out there it sounds — that’s how Eyebot got started
• Full health, dental, and vision insurance
• Commuter support and wellness benefits
• A collaborative office environment in Boston’s North End, with regular team lunches and a great waterfront location
• The chance to build products that improve lives and redefine how vision care is delivered