💼 About This Role

You'll oversee quality systems and compliance for a cell-free DNA testing company. You'll ensure safety, quality, and regulatory adherence across facility operations. This role offers exposure to FDA, ISO13485, and CLIA standards.

🎯 What You'll Do

• Oversee and own a Quality System such as Change Control
• Collect and trend quality metrics
• Review and approve quality records
• Support audits by obtaining documentation

📋 Requirements

• Bachelor's degree in Life Sciences, Engineering, or equivalent
• 5+ years of biotech industry experience
• 3+ years of knowledge with cord blood or transfusion medicine
• Experience with biologics or tissue/organ

✨ Nice to Have

• Prior cryopreservation experience
• Experience in a medical setting
• Experience with CAPA, deviations, complaints

🎁 Benefits & Perks

• 🏥 Medical, dental, vision plans
• 🧬 Free genetic testing for employees and family
• 👶 Pregnancy and baby bonding leave
• 💰 401k benefits and commuter benefits
• 🎁 Employee referral program

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Call· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Assessment· 60 min