Quality Engineer

Position Summary

Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The Quality Engineer works with the QE Manager/QA Director to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position also represents QA on product development projects. The role is hybrid with 1-3 days onsite per week.

• 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 company SOPs and good documentation practices
• Review manufacturing/QC batch records
• Other duties as assigned

• B.S. or equivalent in science, engineering or related field
• At least 6 years of experience in medical diagnostics, CLIA laboratory, or Life Sciences industry; 3 years experience in a quality role
• Audit experience – internal, third‑party, and/or regulatory audits
• American Society of Quality certifications (CQE) preferred

• Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSR (21 CFR 820)
• Computer skills (MS Word, Excel, PowerPoint, etc.)
• Good technical writing and communication skills
• Independent worker, self‑starter with strong organizational and planning skills
• Ability to be productive and successful in an intense work environment

• Hands‑on experience with DNA isolation and purification, PCR, cell culture, sequencing, bioinformatics, etc.
• Demonstrated good judgment, excellent attention to detail, and excellent written, verbal communication and interpersonal skills; flexible and collaborative on multiple projects

Austin, TX

$94,300—$117,900 USD

Competitive benefits: comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401(k) benefits, commuter benefits and much more. We also offer a generous employee referral program.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment. All qualified applicants are encouraged to apply and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

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