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Quality Engineer III

Guilford, Connecticut

Who We Are

Join us on our mission to democratize access to the abundance of health information in the human eye! Here at identifeye HEALTH Inc., we’re pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health monitoring for both ocular and systemic diseases. 

We believe in empowering the individual by building approachable and intuitive products to provide personalized health insights to each and every patient. Our products are portable, affordable, easy to use and connected devices for early disease detection and monitoring.

We are born from 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. We are fostering a culture of technical excellence where you have the opportunity to learn, explore and see your ideas come to life. 

Joining identifeye HEALTH is the opportunity to redesign the future of healthcare through the power of technology. We are here to solve real-world problems and maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

  • Prioritize the Patient - We make products that remove barriers between quality care and the people who need it 
  • Data-Driven Decisions - We search for the best solutions; objective, backed by data, and optimized for speed, simplicity and scale
  • Support Each Other - We celebrate the ideas and contributions of our teammates and recognize that we can only succeed as a team, and when each person feels heard and valued
  • Simplify - We build intuitive solutions to simplify patient care

What You Will Be Doing

This is a hybrid role based out of our east coast office location in Guilford, CT. Local candidates should be comfortable working onsite a minimum of 3 days per week. Candidates in surrounding areas/states must be able to accommodate regular visits to the Guilford, CT office location. 

We're looking for a Quality Engineer to support our medical device manufacturing operations. This role is critical to maintaining compliance with FDA regulations (21 CFR Part 820), ISO 13485 standards, and ensuring product quality throughout the supply chain.

As part of our team, your core responsibilities will be to:

  • Engineering Change Orders (ECOs): Coordinate and manage ECOs, ensuring proper documentation, traceability, and cross-functional approvals
  • Contract Manufacturing Oversight: Collaborate closely with contract manufacturers to ensure adherence to quality standards, resolve quality issues, and support transfer of manufacturing activities
  • Nonconforming Material Reports (NCMRs): Lead investigations, root cause analysis, and disposition of nonconforming materials
  • Supplier Corrective Action Reports (SCARs): Issue, track, and verify effectiveness of SCARs with suppliers and contract manufacturers
  • Approved Supplier List (ASL): Maintain and audit the ASL, ensuring suppliers meet ongoing quality and regulatory requirements
  • Supplier Audits: Plan and execute supplier audits, write reports, and follow up on corrective actions
  • Process Validation: Lead or support IQ/OQ/PQ activities for manufacturing processes and equipment, both internally and at contract manufacturers
  • Device Master Record (DMR) & Device History Record (DHR): Review and maintain accuracy and completeness of DMRs and ensure proper DHR documentation for all manufactured products
  • Manufacturer of Record Compliance: Ensure that all documentation and responsibilities related to the Manufacturer of Record are fulfilled in accordance with regulatory requirements
  • Support the establishment and maintenance of the identifeye Quality Management System
  • Drive continuous improvement of the identifeye Quality Management System
  • Assist with other quality activities to help maintain the effectiveness of the Quality Management System

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

  • Bachelor’s degree in Engineering or a related technical field
  • 3-5+ years of experience in a Quality Engineering role within the medical device industry
  • Deep knowledge of FDA QSR (21 CFR Part 820) and ISO 13485
  • Experience working with contract manufacturers and suppliers in a regulated environment
  • Demonstrated success in managing ECOs, NCMRs, SCARs, process validation, and supplier audits
  • Proficient in quality systems software and Microsoft Office
  • Excellent written and verbal communication skills
  • Ability to travel up to 10% or as needed

Preferred Qualifications:

  • Six Sigma Green or Black Belt certification
  • ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
  • Experience with MDSAP, EU MDR compliance, and international manufacturing partners

What We Offer

  • Fully covered medical insurance plan, and dental & vision coverage. As a health-tech company, we place great worth on our team’s well-being.
  • 401(k) plan. Everyone should be encouraged to save for their retirement adventures!
  • Unlimited PTO policy and flexible work arrangements. We believe in taking personal responsibility for managing our own time, workload and results. 
  • Free onsite meals & kitchen stocked with snacks at our office locations.
  • Annual "Improve Your Work Environment" stipend. We support what you need to be your best self when at work!
  • Professional development reimbursement. Let's grow together!
  • More exciting employee perks... but most importantly, the opportunity to build a revolutionary healthcare product and save millions of lives! 

This job description is not intended to be an all inclusive list of all the duties, responsibilities or qualifications associated with the job. Other duties may be assigned.

identifeye HEALTH Inc. is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.

identifeye HEALTH Inc. does not accept agency resumes.

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