Quality Engineer 2

Summary

Join Natera, a global leader in cell-free DNA testing, as a Quality Engineer II. Support the quality system processes of Natera's CLIA laboratories and activities associated with CE-IVD kits and software. Collaborate with senior QEs to address supplier issues, nonconformances, and corrective actions impacting laboratory operations. This role may also involve representing QA in product development projects. The position requires a BS in a related field and at least 4 years of relevant experience. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, free testing for employees and their families, fertility care benefits, and more.

Requirements

• Position requirements are a B.S. or equivalent in science, engineering or related field
• At least 4 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry
• 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

Responsibilities

• Support internal and external audits (CLIA/CAP, ISO 13485, customer)
• Support CAPA, Deviation, Change Requests and Nonconformance investigation and reporting
• Write/revise procedures and forms
• 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

Preferred Qualifications

• American Society of Quality certifications (CQE)
• 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

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program