Senior Software Quality & Compliance Engineer

Join Personalis, a leading precision medicine company, as a Senior Software Quality & Compliance Engineer. In this high-impact role, you will drive Computer System Validation (CSV) initiatives, enforce regulatory compliance, spearhead risk management, and integrate AI into our quality frameworks. You will also support cybersecurity efforts, serve as the primary software quality subject matter expert during audits, and drive continuous improvement in our electronic quality management system (eQMS). The ideal candidate will have 5-8 years of experience in software quality assurance or compliance within a regulated industry, a BS in computer science or a related field, and deep expertise in varied software development life cycle methodologies.

• Spearhead Computer System Validation (CSV) initiatives, champion the Electronic Quality Management System (eQMS), and pioneer the integration of Artificial Intelligence (AI) into quality frameworks.
• Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms, taking full ownership of authoring, executing, and finalizing critical compliance deliverables.
• Enforce rigorous regulatory alignment across all software development activities, ensuring seamless, continuous compliance with FDA 21 CFR 820, 21 CFR Part 11, EU Annex 11, and IEC 62304 standards.
• Experience: 5-8 years of direct experience in Software Quality Assurance or Compliance within a regulated industry (Diagnostics, MedTech, Pharma, or Biotech preferred)
• Education - BS in computer science or other related areas or equivalent experience
• CSV Expertise: Proven track record of validating complex software systems and maintaining a "validated state" through rigorous change control
• Technical Knowledge: Demonstrate deep expertise in varied SDLC methodologies (including Agile and the V-Model), coupled with extensive hands-on experience driving core quality resolutions, such as Non-Conformances (NC), Corrective and Preventive Actions (CAPA), and Complaint handling
• AI Exposure: Demonstrate a strong working knowledge of AI/ML principles, combined with a clear strategic focus on governing and applying these technologies compliantly within a mature Quality Management System
• EQMS Proficiency: Deep hands-on experience managing or implementing platforms such as MasterControl, Veeva, Arena, or ETQ Reliance
• Hands-on experience within global frameworks—specifically the FDA, IVDR (EU 2017/746), or MDR (EU 2017/745)—is a strong plus
• Exhibit exceptional communication skills, with a proven track record of translating complex regulatory software requirements into clear, actionable guidance for cross-functional teams