Quality Engineer II - Remote

Overview

The Quality Engineer II supports the quality system processes of the Natera CLIA laboratories and activities associated with commercial operations and product lifecycles. The QE II role has combined responsibilities that include management of quality events related to on-market products. They will also work to assist with implementation of post-market product improvements and new product development. This individual will work closely with cross-functional teams to implement the requirements of Natera's Quality Management System across a wide range of projects.

In Short

• 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
• 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
• Support post-market product improvement
• Support the development of new products
• Other duties as assigned

Requirements

• Must have clinical laboratory experience in a CAP/CLIA environment
• Position requirements are a B.S. or equivalent in biology, chemistry, 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
• American Society of Quality certifications (CQE) preferred

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