Added
21 hours ago
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Full time
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Related skills

risk management electromechanical systems software development life cycle iso 13485 fda qsr

📋 Description

  • Support product dev from concept to commercialization
  • Lead design controls and risk management guidance
  • Ensure SDLC compliance with quality processes
  • Collaborate to transfer scalable designs to manufacturing
  • Assist in supplier selection and design verification/validation

🎯 Requirements

  • 8+ years in Quality Engineering; 4+ years in electromechanical or software design
  • Strong design control and risk management background
  • Experience with ISO 13485, ISO 14971, FDA QSR
  • Ability to navigate quality systems with minimal oversight
  • Excellent communication, ability to convey complex info to execs
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