Sr. Software Quality & Compliance Engineer

About the role

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. Onsite: Monday, Tuesday, and Thursday

Responsibilities

• Regulatory Compliance: 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.
• Risk Management : 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).
• AI Integration & Governance : 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.
• Cybersecurity - 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.
• Audit Support : 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.
• eQMS Support: 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.
• Required Qualifications:
• Education - BS in computer science or other related areas or equivalent experience.
• Experience: 5-8 years of direct experience in Software Quality Assurance or Compliance within a regulated industry (Diagnostics, MedTech, Pharma, or Biotech preferred).
• CSV Expertise: Proven track record of validating complex software systems and maintaining a "validated state" through rigorous change control.
• eQMS Proficiency: Deep hands-on experience managing or implementing platforms such as MasterControl, Veeva, Arena, or ETQ Reliance.
• 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.
• Preferred Skills:
• Exhibit exceptional communication skills, with a proven track record of translatin

Additional Information

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.

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