Quality Engineer

Austin, United StatesHybrid

Responsibilities

Support internal and external audits (CLIA/CAP, ISO 13485, customer) •
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 •
Review manufacturing/QC batch records •

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
American Society of Quality certifications (CQE) preferred
Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSRs (21 CFR 820) •
Computer skills (MS Word, Excel, PowerPoint, etc.) •
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
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
Austin, TX $94,300 — $117,900 USD OUR OPPORTUNITY
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.
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

For more information, visit www.natera.com .
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY.

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: •
Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting •
Participate in the management of Approved Suppliers •
Follow established company standard operating procedures and good documentation practices •
experience – internal audits, third party audits and/or regulatory audits •
Independent worker, a self-starter with strong organizational and planning skills •
This may differ in other locations due to cost of labor considerations.
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.