Associate Quality Engineer

POSITION SUMMARY

Associate Quality Engineer (AQE) supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The AQE 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.

PRIMARY RESPONSIBILITIES

• 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 manu