POSITION SUMMARY:
Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with clinical trials. The QE works with senior level QE’s and management to address GCP compliance, supplier issues, non conformances and corrective actions that impact the CLIA laboratory operations.
PRIMARY RESPONSIBILITIES:
Support internal and external audits (GCP sponsor, CLIA/CAP, ISO 13485)
Under limited supervision, collect and trend quality metrics for clinical trials per pre-defined parameters and/or upon request; provide partnered oversight (with QEII or higher) of CAPAs, deviations, and NCRs associated with clinical trials;
Write/revise procedures and forms; submit to Document Control and assist with training as needed
Perform statistical analysis/hypotheses testing (AQL’s etc) as required