We are a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
Quality Engineer
Location
United States
Posted
1 day ago
Salary
0
Seniority
Mid Level
Job Description
Quality Engineer
Natera
• 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.
Job 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.
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