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Akaasa Technologies
Quality Engineer – Test Method Validation (TMV)Akaasa Technologies • Irvine, CA, United States
Quality Engineer – Test Method Validation (TMV)

Quality Engineer – Test Method Validation (TMV)

Akaasa Technologies • Irvine, CA, United States
1 day ago
Job type
  • Full-time
  • Quick Apply
Job description

POSITION

Quality Engineer Test Method Validation (TMV)

Start date & Location

Hybrid Irvine, CA (locals ONLY)

REQUIRED SKILLS

Key Responsibilities

  • Lead and execute TMV remediation activities.
  • Develop, review, execute, and support approval of TMV protocols and final reports.
  • Coordinate and perform validation testing activities, including sample preparation and test execution.
  • Analyze and document validation results and support resolution of issues identified during execution.
  • Apply statistical methods including Gage R&R studies to support validation conclusions.
  • Support operator training to ensure consistent execution of validated test methods.
  • Work cross-functionally with Engineering, Quality, Manufacturing, and other stakeholders.
  • Maintain validation documentation per quality-system requirements.
  • Support remediation schedule and drive TMV activities to completion.

Required Experience

  • Hands-on experience executing TMV activities.
  • Full validation lifecycle experience (protocols, execution, reporting).
  • Strong statistical analysis experience including Gage R&R.
  • Regulated industry experience (medical device preferred).
  • Strong technical writing and documentation skills.
  • Ability to independently execute validation activities.
  • Cross-functional collaboration experience.
  • Strong organizational and communication skills.
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Quality Engineer – Test Method Validation (TMV) • Irvine, CA, United States

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