Quality Engineer

Natera • Austin, TX

14d • $94,300 - $117,900 • Hybrid

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• American Society of Quality certifications (CQE) preferred
• 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

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

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior