Natera

1 week ago

Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 16 hours agoStatus: Live

Job Summary

Support quality system processes for Natera CLIA laboratories, including work tied to CE-IVD kits and software. Partner with the QE Manager/QA Director to address supplier issues, nonconformances, and corrective actions affecting lab operations, and represent QA on product development projects. Manage CAPA/deviations/change requests, support audits (CLIA/CAP, ISO 13485, customer), write and revise procedures, perform statistical analyses, and help ensure compliance with CLIA, FDA QSR, ISO 13485, and HIPAA.

Location: Austin

Workplace: Hybrid

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Support internal and external audits (CLIA/CAP, ISO 13485, customer).
•Manage CAPA, deviations, change requests, and nonconformance investigations and reporting.
•Write/revise procedures and forms, submit to document control, and assist with training.
•Perform statistical analysis and hypotheses testing (e.g., AQLs) as required.
•Support quality system compliance to CLIA, FDA QSR, ISO 13485, and HIPAA, including reviewing manufacturing/QC batch records.

Pay and Benefits

Salary: USD 94,300 - 117,900

Perks:Health InsuranceDentalVisionLife InsuranceDisability Insurance401kCommuter BenefitsParental LeaveFree TestingFertility Care

Key Requirements

•B.S. or equivalent in science, engineering, or a related field.
•At least 6 years of experience in medical diagnostic, CLIA laboratory, or life sciences, with 3 years in a quality role.
•Experience conducting internal, third-party, and/or regulatory audits.
•Preferred: American Society of Quality certifications (CQE).
•Knowledge of CLIA/CAP regulations, ISO 13485, and/or FDA QSRs (21 CFR 820).

Experience:6+ yearsMedical diagnosticsCLIALife sciencesHealthcareRegulatory compliance

Education:Bachelor's

Skills:Technical writingCommunicationIndependent workOrganizational skillsAttention to detail

Certifications:CQE

Languages:English

Tech Stack:MS WordExcelPowerPointAQLDNA IsolationPCRCell CultureSequencingBioinformatics21 CFR 820

Company Brief

Natera

Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.

Industry: Diagnostics

Company Size: Enterprise (1,001+ employees)

Revenue: USD 500M to 1B

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Carlos, United States

Founded: 2004

Website LinkedIn

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Natera

1 week ago

Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 16 hours agoStatus: Live

Job Summary

Location: Austin

Workplace: Hybrid

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Support internal and external audits (CLIA/CAP, ISO 13485, customer).
•Manage CAPA, deviations, change requests, and nonconformance investigations and reporting.
•Write/revise procedures and forms, submit to document control, and assist with training.
•Perform statistical analysis and hypotheses testing (e.g., AQLs) as required.
•Support quality system compliance to CLIA, FDA QSR, ISO 13485, and HIPAA, including reviewing manufacturing/QC batch records.

Pay and Benefits

Salary: USD 94,300 - 117,900

Perks:Health InsuranceDentalVisionLife InsuranceDisability Insurance401kCommuter BenefitsParental LeaveFree TestingFertility Care

Key Requirements

•B.S. or equivalent in science, engineering, or a related field.
•At least 6 years of experience in medical diagnostic, CLIA laboratory, or life sciences, with 3 years in a quality role.
•Experience conducting internal, third-party, and/or regulatory audits.
•Preferred: American Society of Quality certifications (CQE).
•Knowledge of CLIA/CAP regulations, ISO 13485, and/or FDA QSRs (21 CFR 820).

Experience:6+ yearsMedical diagnosticsCLIALife sciencesHealthcareRegulatory compliance

Education:Bachelor's

Skills:Technical writingCommunicationIndependent workOrganizational skillsAttention to detail

Certifications:CQE

Languages:English

Tech Stack:MS WordExcelPowerPointAQLDNA IsolationPCRCell CultureSequencingBioinformatics21 CFR 820

Company Brief

Natera

Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.

Industry: Diagnostics

Company Size: Enterprise (1,001+ employees)

Revenue: USD 500M to 1B

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: San Carlos, United States

Founded: 2004

Website LinkedIn