Quality Assurance Engineer, Senior Staff

Confluent Medical

Costa Rica
Hybrid
Bachelor degree in engineering discipline
6-7 years manufacturing and quality systems experience
Proficient oral and written english level
Confluent Medical is seeking a Senior Staff Quality Assurance Engineer to join their team in Costa Rica. This role involves leading problem-solving projects, ensuring compliance with quality standards, and participating in design and validation processes for medical devices

Job Summary

  • The role involves leading problem-solving projects and providing technical guidance for life-saving medical devices.
  • Candidates will develop validation protocols, manage risk assessments like PFMEA, and lead CAPA initiatives for quality system improvement.
  • The position requires independent judgment to plan complex engineering work while ensuring compliance with federal and company regulations.

Matching Summary

Match Score: 85

Confluent Medical is seeking a Senior Staff Quality Assurance Engineer to join their team in Costa Rica. This role involves leading problem-solving projects, ensuring compliance with quality standards, and participating in design and validation processes for medical devices.

Skills & Requirements

Must-have

  • Bachelor degree in engineering discipline
  • 6-7 years manufacturing and quality systems experience
  • Proficient oral and written English level
  • Knowledge of basics statistics and Minitab
  • Experience with process validation and software validation

Nice-to-have

  • Certified Quality Engineer credential
  • Black Belt certification
  • Lead auditor certification in ISO13485
  • Internal auditor experience in ISO13485
  • Medical device industry experience

Key Requirements

  • Bachelor degree in related engineering discipline
  • 6-7 years of related experience
  • Certified Quality Engineer (preferred)
  • Black Belt certification (preferred)
  • Lead auditor certification in ISO13485 (preferred)

Work Rights

Not specified

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