Quality Engineer – Medical Diagnostics | CAPA & Audits | Hybrid

Natera; Austin (TX); Hybrid; USD 94,000 - 118,000; Full time

Job summary

Natera is seeking a Quality Engineer to support CLIA laboratory quality systems and CE-IVD kit/software activities. Hybrid role with 1–3 days onsite weekly, collaborating with QE Manager/QA Director on supplier issues, nonconformances, and corrective actions affecting lab operations.

Ideal candidates hold a science/engineering BS and 6+ years in medical diagnostics or life sciences, with QA experience and strong documentation skills.

Qualifications

• Bachelor's degree (or equivalent) in science, engineering, or related field.
• Minimum 6 years in medical diagnostic, CLIA lab, or life sciences industry; 3 years in a quality role.
• Audit experience—internal, third-party, and/or regulatory.
• American Society of Quality certification (CQE) preferred.

Responsibilities

• Support internal and external audits (CLIA/CAP, ISO 13485, customer).
• Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting.
• 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 QSR, ISO 13485, and HIPAA.
• Participate in the management of Approved Suppliers.
• Follow established SOPs and good documentation practices.
• Review manufacturing/QC batch records.
• Other duties as assigned.

Skills

Audit readiness

Regulatory awareness

Technical writing

Independent worker

Organizational skills

Education

B.S. in science, engineering, or related field

Tools

MS Word

Excel

PowerPoint

Job description

Natera is seeking a Quality Engineer to support CLIA laboratory quality systems and CE-IVD kit/software activities. Hybrid role with 1–3 days onsite weekly, collaborating with QE Manager/QA Director on supplier issues, nonconformances, and corrective actions affecting lab operations.

Ideal candidates hold a science/engineering BS and 6+ years in medical diagnostics or life sciences, with QA experience and strong documentation skills.