Quality Assurance Engineer

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The Quality Assurance Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with clinical trials, ensuring compliance and addressing quality issues.

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
• 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

Requirements:

• Position requirements are 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
• Basic Knowledge of GCLP, ICH-E6 and ISO 20916, CLIA/CAP regulations and standards, ISO 13485
• Computer skills (MS Word, Excel, PowerPoint, etc.)
• Good technical writing and communication skills
• Independent worker, a self-starter with strong organizational and planning skills
• Has an ability to be productive and successful in an intense work environment
• American Society of Quality certifications preferred
• Working knowledge of GCLP, ICH-E6 and ISO 20916 preferred
• Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects