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Founded in 2004 and led by CEO Steve Chapman, Natera is a company in the biotechnology market that offers genetic testing and diagnostics on a global scale. Ope
Quality Assurance Engineer
Location
United States
Posted
59 days ago
Salary
$94.3K - $117.9K / year
Seniority
Senior
Job Description
Quality Assurance Engineer
Natera
• Support internal and external audits (GCP sponsor, CLIA/CAP, ISO 13485). • Collect and trend quality metrics for clinical trials per pre-defined parameters and/or upon request; provide partnered oversight 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 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).
Job Requirements
- 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.
Benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for employees and their immediate families, alongside fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program!
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