Sr. Software Quality & Compliance Engineer

Personalis, Inc•Fremont, CA

4d•$130,000 - $155,000•Hybrid

About The Position

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. Personalis is based in Fremont, California. We are seeking a proactive, self-motivated and detail-oriented Senior Software Quality & Compliance Engineer to serve as the vital bridge between innovative software development and rigorous regulatory and compliance standards. In this high-impact role, you will spearhead Computer System Validation (CSV) initiatives, champion our Electronic Quality Management System (eQMS), and pioneer the integration of Artificial Intelligence (AI) into our quality frameworks. The ideal candidate will ensure that Personalis software products and internal systems are high-performing, compliant with global standards (including FDA 21 CFR Part 11 and 820, ISO 13485, and IEC 62304 etc), and primed for the next generation of automated quality oversight.

Requirements

BS in computer science or other related areas or equivalent experience.
5-8 years of direct experience in Software Quality Assurance or Compliance within a regulated industry (Diagnostics, MedTech, Pharma, or Biotech preferred).
Proven track record of validating complex software systems and maintaining a "validated state" through rigorous change control.
Deep hands-on experience managing or implementing platforms such as MasterControl, Veeva, Arena, or ETQ Reliance.
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.
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.

Nice To Haves

Exhibit exceptional communication skills, with a proven track record of translating complex regulatory software requirements into clear, actionable guidance for cross-functional teams.
Hands-on experience within global frameworks—specifically the FDA, IVDR (EU 2017/746), or MDR (EU 2017/745)—is a strong plus.

Responsibilities

Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms.
Take full ownership of authoring, executing, and finalizing critical compliance deliverables, including Validation Plans, IQ/OQ/PQs, and Validation Summary Reports.
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.
Spearhead proactive Risk Assessments (FMEA) to pinpoint potential software hazards early, implementing robust mitigation strategies across the entire CSV and Software Development Life Cycle (SDLC).
Partner with Quality leadership to integrate AI-driven tools into the QMS.
Develop robust, risk-based frameworks for AI validation to ensure all machine learning models utilized in quality processes remain transparent, traceable, and fully compliant.
Champion a secure-by-design culture by collaborating seamlessly with IT, ensuring our digital infrastructure and software products maintain a proactive, audit-ready posture against emerging cybersecurity threats.
Serve as the primary SW Quality Subject Matter Expert (SME) during internal and external audits, confidently presenting and defending validation packages and quality processes to regulatory bodies.
As the SW Quality Subject Matter Expert, driving continuous improvement in system configuration and user workflows champion uncompromising data integrity across foundational quality modules in the eQMS such as Document Control, CAPA, and Change Management.
Drive rigorous cross-functional alignment by partnering closely with Software Development and SQA teams: Provide expert guidance on accurate generation of essential design control documentation, including Software/System Requirement Specifications, Architecture, Testing protocols/reports, and System Risk Analyses.