Full-Time

Senior Quality Engineer

Posted on 8/31/2023

 identifeye HEALTH

identifeye HEALTH

11-50 employees

Portable device for non-invasive health diagnostics

Data & Analytics
Hardware

Senior

Branford, CT, USA

Required Skills
Agile
Management
Requirements
  • Bachelor’s Degree in engineering or STEM-related field
  • 5 years of quality or regulatory experience in FDA and ISO 13485 regulated environment
  • Experience with ISO 14971 and IEC 62304
  • Experience as quality representative on cross-functional teams
  • Ability to work onsite in Guilford, CT or Redwood City, CA preferred
  • ASQ, CQE, CQA, or ISO 13485 Auditor certifications preferred
  • Experience with 510(k) or PMA submissions preferred
  • Experience with Jira or similar requirements management software preferred
  • Experience with Omnify, Agile, or similar Product Lifecycle Management software preferred
Responsibilities
  • Serve as quality representative on new product development projects
  • Support the establishment and improvement of the Quality Management System
  • Lead product risk management within product teams
  • Ensure Software Development Life Cycle compliance
  • Assist with design transfer and supplier onboarding

Identifeye HEALTH is revolutionizing the way we approach health diagnostics with their cutting-edge portable device that combines retinal scanning and chemical sensors. This approach not only enhances the accessibility of advanced health screenings but also ensures a non-invasive procedure, making it a convenient option for routine health monitoring. The company’s commitment to integrating multiple imaging technologies indicates a forward-thinking culture that values innovation and patient convenience, making it an inspiring place to work for those passionate about improving healthcare through technology.

Company Stage

Series B

Total Funding

$80M

Headquarters

Guilford, Connecticut

Founded

2018

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

-8%

2 year growth

2%
INACTIVE