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.
Support Quality systems compliance to CLIA, FDA QMSR, ISO 13485, and HIPAA.
Participate in clinical trial related meetings (as needed).
Follow established company standard operating procedures and good documentation practices.
Partner across functions to provide review of documents and records.
Expand skills as QA professional through execution of duties, independent learning, and training courses.
Enhance knowledge in clinical regulations and guidelines (GCLP, ICH E6, CFR's, ISO 20916, IVDR).

A B.S. or equivalent in science, engineering or related field.
2-3 years of work experience in Biotech industry, medical device industry preferred or a relevant combination of skills, education, and experience in Quality Assurance.
Audit experience – internal audits, third party audits and/or regulatory audits.
American Society of Quality certifications preferred.

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

Quality Assurance Engineer

Key skills