Quality Engineer

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Support internal and external audits (CLIA/CAP, ISO 13485, customer). • Support CAPA, Deviation, Change Requests and Nonconformance investigation and reporting. • Write/revise procedures and forms. • Perform statistical analysis/hypotheses testing (AQL’s etc) as required. • Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA. • Participate in the management of Approved Suppliers. • Follow established company standard operating procedures and good documentation practices. • Review manufacturing/QC batch records. • Other duties as assigned.

🎯 Requirements

• B.S. or equivalent in science, engineering or related field. • At least 4 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry; 2 years experience in a Quality role preferred. • Audit experience – internal audits, third party audits and/or regulatory audits. • American Society of Quality certifications (CQE) preferred.

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. • Free testing for employees and their immediate families. • Fertility care benefits. • Pregnancy and baby bonding leave. • 401k benefits. • Commuter benefits. • Generous employee referral program.