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QA Design Transfer Engineer I/II - Pearland, TX

Merit Medical · Pearland, TX

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Role summary

Merit Medical seeks a QA Design Transfer Engineer to oversee design-to-manufacturing transitions for medical devices. The role involves coordinating process validation, managing risk analyses, and ensuring regulatory compliance across assigned product lines in a Pearland, TX facility.

What they're looking for

  • Bachelor's degree in engineering or related discipline
  • Working knowledge of 21 CFR 820, ISO 13485, ISO 14791 standards
  • Experience with quality control, statistical methods, and manufacturing tools
  • Proficiency with spreadsheets, word processing, and database software
  • Knowledge of applicable regulatory agency regulations
  • Medical device industry experience preferred
  • ASQ Certified Quality Engineering certification preferred

What you'll be doing

  • Guide design team through process validation, test method validation, and device master record creation
  • Coordinate and lead process risk analysis and risk management activities across assigned products
  • Review, approve, and generate engineering change notifications for verification and validation procedures
  • Investigate nonconformance records to determine root causes and implement corrective actions
  • Mentor engineers and technicians on quality system compliance and engineering projects

Privacy & handoff

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What RoleLantern checked

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RoleLantern checkedNeeds clarity
Date posted4 days ago
Last source check1 day ago
Salary listedNeeds clarity
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