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Associate Quality Engineer

4 hours, 10 minutes ago
United States
Full-time
Junior
QA Engineer
Quality Assurance and Testing
HIPAA
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 80

Description

  • Support internal and external audits for CLIA/CAP, ISO 13485, and customer requirements.
  • Investigate and report on CAPAs, deviations, change requests, and nonconformances.
  • Write and revise procedures, forms, and other quality system documentation.
  • Perform statistical analysis and hypothesis testing, including AQL-based assessments, as needed.
  • Support quality systems compliance with CLIA, FDA QSR, ISO 13485, and HIPAA requirements.
  • Participate in the management of approved suppliers.
  • Review manufacturing and QC batch records.
  • Follow company standard operating procedures and good documentation practices.
  • Represent Quality Assurance on product development projects, as needed.

Requirements

  • B.S. degree or equivalent in science, engineering, or a related field.
  • At least 4 years of experience in the medical diagnostic, CLIA laboratory, or life sciences industry.
  • 2 years of quality role experience preferred.
  • Experience with internal, third-party, and/or regulatory audits.
  • Knowledge of CLIA/CAP regulations, ISO 13485, and/or FDA QSRs (21 CFR 820).
  • Proficiency with MS Word, Excel, PowerPoint, and other standard computer tools.
  • Strong technical writing and communication skills.
  • Ability to work independently as a self-starter with strong organizational and planning skills.
  • Ability to be productive in a fast-paced, high-intensity work environment.
  • ASQ CQE certification preferred.
  • Hands-on experience with DNA isolation and purification, PCR, cell culture, sequencing, and bioinformatics preferred.
  • Strong judgment, attention to detail, interpersonal skills, flexibility, and the ability to collaborate across multiple projects preferred.

Benefits

  • Competitive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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