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