Full-Time

Quality Documentation Specialist

Posted on 5/9/2024

Fluxergy

Fluxergy

51-200 employees

Open platform for multimodal diagnostic testing

Data & Analytics
Hardware
Industrial & Manufacturing

Entry

Irvine, CA, USA

Requirements
  • Demonstrated experience in document processing and/or management
  • An understanding of document control procedures
  • Experience in a medical device manufacturing environment is a plus
  • Proficiency in Microsoft Office Suite
Responsibilities
  • Maintain a basic understanding of Fluxergy's QMS in relation to ISO 13485/FDA QMSR requirements
  • Demonstrate proficiency in managing QMS documentation processes
  • Provide support in auditing and compliance-related activities
  • Identify trends in documentation and compliance deficiencies
  • Propose and implement optimizations to streamline processes

Fluxergy is pioneering an open platform for multimodal, point-of-care assay development and testing, utilizing technologies such as PCR, immunochemistry, chemistry testing, and microscopy testing to enable fast, accurate, and affordable diagnostics for a wide range of applications. Their platform aims to bring the variety of tests found in central labs to the palm of your hand, with the ability to detect genes, proteins, small molecules, and cells using the same analyzer.

Company Stage

Series C

Total Funding

$80M

Headquarters

Irvine, California

Founded

2011

Growth & Insights
Headcount

6 month growth

9%

1 year growth

13%

2 year growth

34%