Document Control Specialist

Tesseract Health

Tesseract Health

Guilford, CT, USA
Posted on Friday, October 20, 2023

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

As a member of our Quality and Regulatory team, the Document Control Specialist will play a key role in the document and data control of quality documents at identifeye HEALTH, as well as the maintenance and improvement of a compliant and effective Document Control System.

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

  • Support the maintenance and improvement of the identifeye HEALTH’s Document Control System
  • Maintain Master Document List, Quality System Record, and other related quality documentation
  • Assign document numbers for controlled documentation, including marketing material
  • Review documents to ensure compliance with Good Documentation Practices and identifeye HEALTH procedures, and update as needed
  • Coordinate routing and approval of new and revised quality documents
  • Maintain training matrix, generate training plans for new team members, and work cross-functionally to ensure compliance with the identifeye HEALTH quality training program
  • Ensure current versions of quality documents are easily accessible to all team members

What We Are Looking For

Baseline Skills, Experiences, & Attributes:

  • Bachelor’s degree in engineering or other STEM-related field, or equivalent industry experience
  • At least 1 year of hands-on experience in a U.S. FDA and ISO 13485 regulated environment OR at least 3 years experience in an ISO 9001 regulated environment
  • Excellent attention to detail and follow through
  • Proficient in Google Workplace, DocuSign, and Microsoft Office suite
  • Proven ability to work in a fast-paced environment and adjust priorities as needed
  • Ability to work onsite 3 days a week in our Guilford, CT office

Preferred Qualifications

  • Experience implementing an electronic quality management system
  • Familiarity with Omnify Empower Product Lifecycle Management system

What We Offer

Anticipated Salary Range: $56,000 to $68,000 annually. The base salary range represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range based on various factors including but not limited to work location, operational needs, potential employee qualifications and other considerations permitted by law. The range listed is just one component of our total compensation package for employees. Other rewards may include annual bonuses, equity and program-specific awards. In addition, we provide a variety of other benefits to employees including but not limited to:
  • 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!
  • Flexible PTO policy and remote/hybrid 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!

identifeye HEALTH Inc. does not accept agency resumes.

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.