QA Specialist I

generis tekIrving, TX
Onsite

About The Position

This is a contract role for a QA Specialist in Irving, TX, with a duration of 6 months. The position involves supporting the final release of finished medical device products, reviewing Device History Records (DHR) for accuracy, completeness, and compliance, and verifying that released products meet established quality standards prior to shipment. The role also includes reviewing both 3rd floor Instrument products and ACP jobs, identifying documentation errors, escalating quality issues, and collaborating with cross-functional teams to resolve issues and support continuous improvement.

Requirements

  • 0–2 years of quality, manufacturing, or documentation review experience.
  • Ability to work with minimal guidance and follow defined procedures.
  • Strong attention to detail
  • Effective communication
  • Problem solving ability
  • Teamwork and collaboration
  • Ability to work independently with minimal supervision

Nice To Haves

  • Quality Assurant background is a plus
  • Quality Assurance (QA) experience
  • Batch Release experience
  • Non-Conformance documentation
  • Process improvement involvement

Responsibilities

  • Support final release of finished medical device products.
  • Review Device History Records (DHR) for accuracy, completeness, and compliance.
  • Verify that released products meet established quality standards prior to shipment.
  • Review both 3rd floor Instrument products and ACP jobs.
  • Identify documentation errors and escalate quality issues as needed.
  • Collaborate with cross functional teams to resolve issues and support continuous improvement.
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