Natera is hiring a
Product Software Validation Specialist

Summary

Join Natera, a global leader in cell-free DNA testing, as a Software Compliance Specialist to support the quality system and processes of our CLIA laboratories. This role represents compliance requirements related to software implementation and product development projects, leads audits, and ensures compliance with regulatory requirements.

Requirements

• 8 yrs experience in Biotech industry preferred or a relevant combination of skills, education and experience
• Bachelor's degree in Life Sciences, Engineering, Software or equivalent
• ASQ or SQA certification preferred

Responsibilities

• Lead validation & verification (V&V) & risk management (sFMEA) activities
• Review software change requests and maintenance updates following change control and maintenance release process
• Support preparation and execution of internal and supplier audits as well as hosting external audits related to software
• Participate and/or lead computer system validation / Spreadsheet validation projects
• Participate in development of regulatory content for submissions to regulatory authorities
• Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits