Quality Assurance Intern

Spectral MD IncDallas, TX
Onsite

About The Position

The Quality Assurance Intern supports the cross-functional Engineering and the Quality Assurance team by performing various quality activities related to design, development, testing and manufacturing of a medical imaging device while continuously maintaining and improving of the Spectral MD’s Quality System in compliance with applicable regulations and standards.

Requirements

  • Currently pursuing a bachelor’s degree in Science or Engineering
  • Experience working in cross-functional organization.
  • Excellent computer skills including Microsoft Office suite of products (Word, PowerPoint, Excel, Power BI, SharePoint, etc.), as well as Data Analysis, Scripting Automation and Visualization Skills
  • Strong communication and interpersonal skills.

Nice To Haves

  • Familiarity with 21 CFR 820
  • Familiarity with ISO 13485

Responsibilities

  • Ensure all project documents are filed and updated regularly in the Design History File for each project.
  • Maintain Device Master Record and organize engineering drawings.
  • Track Engineering Change Order action items, closeout, and filing.
  • Manage equipment calibration and inventory.
  • Monitor and assist with employee training and training records as required for compliance.
  • Assist with revision of quality system-related documents and records.
  • Assist with developing and maintaining tracking system for Quality Systems metrics.
  • Assist in other quality systems responsibilities requested by Quality Manager.
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