20h ago

Staff Quality Compliance Engineer

San Jose, CA

$144k-$169.8k / year

full-timelead Hybridhealthcare

💼 About This Role

You'll lead compliance and post-market surveillance initiatives for a surgical robotics company focused on BPH treatment. Your impact will drive continuous improvement across the Quality Management System.

🎯 What You'll Do

  • Lead special projects for Quality Compliance and Post-Market Surveillance
  • Proactively identify process risks and improvement opportunities within QMS
  • Represent Quality Compliance on cross-functional initiatives
  • Perform and lead CAPA including root cause investigations

📋 Requirements

  • Bachelor's in engineering or science
  • 8 years progressive medical device industry experience
  • 5 years in quality systems or compliance roles
  • Knowledge of FDA QSR/QMSR, ISO 13485, MDSAP, EU MDR

✨ Nice to Have

  • Master's degree in engineering or science
  • Prior supervisory or managerial experience

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

  1. 1Recruiter Screen· 30 min
  2. 2Hiring Manager Interview· 60 min
  3. 3Technical Interview· 60 min
  4. 4Offer· 15 min
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