Head of Quality jobs in United States
cer-icon
Apply on Employer Site
company-logo

Eyebot · 1 day ago

Head of Quality

positionBoston
timeFull-time
remoteOnsite
seniorityDirector/Executive
money$150K/yr - $220K/yr

Eyebot is an outcome-focused technology company on a mission to make vision care accessible to everyone. They are looking for a Head of Quality to build and lead the quality and regulatory function for their medical device operations as they scale and prepare for international expansion.

Artificial Intelligence (AI)EyewearHealth DiagnosticsRobotics
check
H1B Sponsor Likelynote

Responsibilities

Drive regulatory strategy and submissions for U.S. and international markets, including EU MDR, UKCA, and other global certifications, while maintaining ongoing compliance and reporting
Develop and lead Eyebot’s quality management system (QMS) to ensure compliance with FDA, ISO 13485, and international regulations

Qualification

Medical device quality systemsFDA requirementsEU MDR knowledgeQMS implementationRisk managementDesign controlsCAPADocument controlRegulatory reportingLow ego mindsetCollaborationOwnershipResponsibility

Required

Deep experience with medical device quality systems
Strong understanding of FDA requirements, including 510k exempt pathways
Knowledge of EU MDR and international regulatory frameworks
Experience with QMS implementation and ISO 13485
Experience with risk management, design controls, CAPA, document control
Ability to collaborate with engineering and operations in a fast moving environment
Hands-on experience leading medical device certifications in one or more of the following regions: EU (MDR), UK (UKCA), Canada (Health Canada / MDSAP), Mexico (COFEPRIS)
Demonstrated experience working directly with Notified Bodies and regulatory authorities
Strong working knowledge of EU MDR, including PRRC (Article 15) responsibilities
Experience owning PMS, vigilance, and regulatory reporting processes

Preferred

Previous experience formally acting as a PRRC or equivalent regulatory accountability role
Experience supporting EU MDR Class IIa medical device certifications
Experience scaling quality and regulatory systems in a high-growth startup environment
Experience supporting or fulfilling MDR PRRC accountability requirements, including preparation and maintenance of MDR technical documentation and hands-on support of MDR CE certification activities with Notified Bodies

Benefits

Flexible work schedule with unlimited PTO.
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.

Company

Eyebot

twittertwittertwitter
company-logo
Eyebot develops an eye examination technology to eliminate barriers and provide quality vision care.
dateFounded in 2021
location
Boston, Massachusetts, USA
people-size11-50 employees
web-link
http://www.eyebot.co

H1B Sponsorship

Eyebot has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)

Funding

Current Stage
Early Stage
Total Funding
$29.93M
Key Investors
General CatalystMassVenturesNational Science Foundation
2025-08-26Series A· $20M
2025-05-16Grant· $0.2M
2024-06-06Seed· $6M

Leadership Team

leader-logo
Matthias Hofmann
Co-founder & CEO
linkedin
leader-logo
Jack Moldave
Co-Founder & CTO
linkedin

Recent News

Engadget
Engadget's best of CES 2026: All the new tech that caught our eye in Las Vegas
2026-01-09
PR Newswire
Eyebot and The Framery at 1-800 Contacts Debut End-to-End Optical Experience at CES 2026
2026-01-06
Crunchbase News
The Non-Humanoid Robot Startups Are Rising Too
2025-11-01
Company data provided by crunchbase