Head of Quality

Reposted Yesterday
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Boston, MA, USA
In-Office
150K-220K Annually
Senior level
Beauty • Wearables
The Role
The Head of Quality will lead quality and regulatory functions for Eyebot's medical devices, ensuring compliance with regulations, managing quality systems, and collaborating with engineering teams.
Summary Generated by Built In
About Eyebot

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.

About The Role

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.

What You’ll Do:

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.

What We're Looking For:Required Qualifications:
  • 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

Preferred 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

Personality:
  • 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.

What We Offer:
  • Starting target salary in the range of 150k-220k, along with meaningful equity.

  • 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.

Skills 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 regions: EU, UK, Canada, Mexico
  • Demonstrated experience working directly with Notified Bodies and regulatory authorities
  • Strong working knowledge of EU MDR including PRRC responsibilities
  • Experience owning PMS vigilance and regulatory reporting processes
  • 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

Eyebot Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eyebot and has not been reviewed or approved by Eyebot.

  • Fair & Transparent Compensation Job postings display explicit salary bands across several roles, and a firsthand account cites “very good” base pay at $25/hour. These publicly shared ranges are characterized as competitive for Boston health‑tech, creating clearer expectations.
  • Healthcare Strength Job materials consistently list full health, dental, and vision insurance as part of the package. This signals robust core medical coverage for an early‑stage startup.
  • Leave & Time Off Breadth Listings describe a flexible schedule with unlimited PTO. The breadth of time off is positioned as a standard element of the offer.

Eyebot Insights

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The Company
HQ: Boston, Massachusetts
29 Employees
Year Founded: 2021

What We Do

Our mission is to make vision care accessible to everyone, equally, at the touch of a button. The demand for vision care is growing fast while eye doctor availability is not keeping up. As a result, millions of people are behind on their vision care or unable to access it. We see a future where technology works seamlessly with Eye Care Professionals to expand access to personalized vision care for all those who need it. Eyebot is funded by top VCs and the National Science Foundation.

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