5h ago

Lead Quality Audit Specialist

Durham, NC

~$115,000-$145,000 / yearest.

full-timesenior Hybridhealthcare

💼 About This Role

You'll develop and manage the internal audit program for a healthcare company focused on early cancer detection. Your work will ensure compliance with FDA and ISO standards, directly supporting our mission to change cancer mortality.

🎯 What You'll Do

  • Create annual internal audit schedules and coordinate cross-functional teams
  • Perform internal audits and analyze records for regulatory compliance
  • Document audit findings and monitor corrective actions until closure
  • Develop and maintain QMS policies, procedures, and metrics dashboards

📋 Requirements

  • BA/BS with 5+ years relevant experience in life sciences
  • Lead Auditor Certification required
  • Working knowledge of FDA QMSR/cGMP and ISO 13485/14971

✨ Nice to Have

  • Experience in FDA medical device/IVD regulated environment
  • Experience with electronic QMS lifecycle management

🎁 Benefits & Perks

  • 🏖️ Flexible work arrangement with hybrid schedule
  • 🏥 Health insurance including medical, dental, vision
  • 💰 Equity and 401(k) matching
  • 🏠 Remote work options available
  • 📈 Professional development opportunities
0 0 0