Quality Engineer

Responsibilities

• Create, revise, and update laboratory, equipment, facility, and HIPAA compliance processes
• Develop and implement quality system documentation including operating procedures and work instructions
• Support compliance activities such as non-conformances, CAPA, audits, and complaints investigations
• Conduct internal and external audits for FDA, HIPAA, and Notified Body compliance
• Perform Risk Assessments using FMEA, FTA, and Risk Analysis
• Monitor laboratory workflows for compliance with CLIA, GMP, GLP, and GCP
• Perform statistical analysis, hypothesis testing, and implement Statistical Process Control (SPC)
• Maintain quality systems compliance to ISO 13485 and FDA QSR
• Manage approved suppliers and review analytical testing data
• Provide expertise on healthcare data privacy regulations and HIPAA security practices

Requirements

• B.S. or equivalent in science, engineering, or a related field
• 2 to 5 years of experience in quality process improvement within medical devices, CLIA laboratories, or Life Sciences
• Experience in 21 CFR 820 QSR, ISO 13485, GMP, GLP, GCP, or HIPAA environments
• Extensive experience with ISO 14971
• Proficiency with MS Office (Word, Excel, PowerPoint)
• Strong technical writing and communication skills

Preferred Qualifications

• ASQ certifications (CQE, CMQ/OE)
• Hands-on experience with DNA Isolation, PCR, Cell Culture, Sequencing, or Bioinformatics

About the Company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The company aims to make personalized genetic testing and diagnostics part of the standard of care to enable earlier and more targeted medical interventions.