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.
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