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
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