Quality Engineer - Medical Diagnostics (Hybrid Job Austin area,Texas USA,Quality Assurance

Position: Quality Engineer - Medical Diagnostics (Hybrid)

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.

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

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. This may differ in other locations due to cost of labor considerations.

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…