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