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Tesseract
Guilford, CT | Full Time
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identifeye HEALTH Inc.
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Manufacturing Quality Engineer
Tesseract Guilford, CT
Full Time | Preschool & Daycare 6 Months Ago
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Tesseract is Hiring a Manufacturing Quality Engineer Near Guilford, CT

Who We Are

Tesseract’s mission is to democratize healthcare delivery to everyone on a global scale. We are reinventing medical devices to leverage the health information in the human eye and championing a new era of healthcare by creating portable, affordable, easy to use, connected devices for early disease detection and monitoring. Tesseract is well-funded and recently raised a series B round of $80M.

We are part of 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. Our 4Catalyzer sister companies include Butterfly Network, the first whole-body Ultrasound-on-ChipTM, and Hyperfine, the first FDA-cleared portable MRI. We are fostering a culture of technical excellence and positive teamwork to solve real-world problems that help improve healthcare for billions of people around the world.

Joining Tesseract is the opportunity to redesign the future of healthcare through the power of technology. Join us on this journey to maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love.

What We Live By

  • Patients First. We are driven to make products that will improve people’s lives.
  • Data-Driven. We search for the best solutions: objective, backed by data, and optimized for speed, simplicity and scale.
  • Team-Oriented. We collaborate with and support each other every step of the way.

What You Will Be Doing

The Manufacturing Quality Engineer will play a key role in the production of high quality and compliant medical devices at Tesseract, as well as in the maintenance of compliant and effective supplier, production, and documentation practices.

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

  • Support establishment and maintenance of compliant production processes, including documentation, validation, inspection, nonconforming materials, and traceability
  • Lead supplier quality activities such as Supplier Quality Audits, First Article Inspections, and Supplier Corrective Action Requests
  • Assist with process validation, including IQ/OQ/PQ
  • Support generation of compliant documentation (DHRs, inspection records, calibration records, etc.)
  • Work with manufacturing team to complete pFMEAs and support the risk management process
  • Work with manufacturing team to establish and monitor key metrics
  • 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, preferably in engineering or other STEM-related field
  • At least 1 year of hands-on quality or manufacturing experience in a U.S. FDA and ISO 13485 regulatory environment OR at least 3 years in quality or manufacturing role in another highly regulated field (such as aerospace or automotive)

Preferred Qualifications

  • ASQ, CQE, CQA, or other ISO 13485 auditor certifications
  • Experience with Omnify, Agile, or similar Product Lifecycle Management software

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.
  • Competitive salaried compensation & equity. You should feel appropriately valued and have a stake in our success!
  • 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 Guilford, CT campus. 
  • 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! 

For this role, we provide visa assistance for qualified candidates. 

Tesseract does not accept agency resumes.

Tesseract 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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Preschool & Daycare

POST DATE

09/03/2022

EXPIRATION DATE

11/07/2022

WEBSITE

sunrisepreschools.com

HEADQUARTERS

GLENDALE, AZ

SIZE

25 - 50

TYPE

Private

CEO

TAMMY BOWMAN

REVENUE

$5M - $10M

INDUSTRY

Preschool & Daycare

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The following is the career advancement route for Manufacturing Quality Engineer positions, which can be used as a reference in future career path planning. As a Manufacturing Quality Engineer, it can be promoted into senior positions as an Industrial Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manufacturing Quality Engineer. You can explore the career advancement for a Manufacturing Quality Engineer below and select your interested title to get hiring information.