5h ago

Senior Supplier Quality Engineer

Durham, North Carolina

~$110,000-$140,000 / yearest.

G
full-timesenior Hybridhealthcare / biotechnology

💼 About This Role

You'll lead supplier qualification and quality system improvements for a healthcare company pioneering early cancer detection using next-generation sequencing. You'll ensure compliance with medical device regulations and drive supplier performance across the organization.

🎯 What You'll Do

  • Lead supplier qualification and performance activities.
  • Support Quality Management Review and metric generation.
  • Conduct supplier audits and manage corrective actions.
  • Collaborate with cross-functional teams on quality improvements.

📋 Requirements

  • Bachelor’s degree in science, engineering, or technical area.
  • Minimum of 5 years in a clinical laboratory or IVD/pharma QMS.
  • Experience with regulations including ISO 13485 and CAP/CLIA.
  • Experience supporting regulatory inspections and managing corrective actions.

✨ Nice to Have

  • Master’s degree in a technical area or MBA.
  • Next Generation Sequencing (NGS) experience.
  • ASQ Certified Quality Auditor or Engineer certification.

🎁 Benefits & Perks

  • 🏖️ Flexible work arrangement with hybrid schedule.
  • 🩺 Health insurance and wellness programs.
  • 💰 Competitive compensation and equity.
  • 📈 Career development opportunities in a growing company.
0 0 0