Quality Engineer

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

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 QE Manager/QA Director to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position will also represent QA on product development projects. Position will be hybrid with 1-3 days onsite a week.

PRIMARY 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 company standard operating procedures and good documentation practices
• Review manufacturing/QC batch records
• Other duties as assigned

QUALIFICATIONS:

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

KNOWLEDGE, SKILLS, AND ABILITIES:

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

Preferred skills

• Hands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.
• Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects

Austin, TX

$94,300 — $117,900 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

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

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/