[Hiring] Quality Assurance Engineer @Natera

Role Description

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.

Qualifications

• 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

Requirements

• 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
• Expands skills as QA professional through execution of duties, independent learning, and training courses
• Enhances knowledge in clinical regulations and guidelines (GCLP, ICH E6, CFR's, ISO 20916, IVDR)
• Other duties as assigned

Benefits

• 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

Company Description

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.