Quality Engineer II - Remote

Overview

The Quality Engineer II supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The QE II works with senior level QE’s to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position may also represent QA on product development projects.

In Short

• 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 working 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
• Free testing for employees and their immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program