Associate Quality Engineer

Natera is a global leader in cell-free DNA testing, focusing on oncology, women’s health, and organ health. They are seeking an Associate Quality Engineer to support quality system processes in their CLIA laboratories and work with senior level engineers to address supplier issues and nonconformances.

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

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; 2 years experience working in a Quality role preferred
• 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
• 2 years experience working in a Quality role preferred
• 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