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Senior Software Quality & Compliance Engineer at Personalis, Inc - ApplyBlast

Senior Software Quality & Compliance Engineer

Personalis, Inc

4 months ago

Fremont, California, United States

Hybrid

Full Time

Senior

0 applicants

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About this role

The Senior Software Quality & Compliance Engineer will lead computer system validation initiatives, manage the electronic quality management system, and integrate AI-driven tools into quality processes. This role ensures software products meet global regulatory standards such as FDA 21 CFR Part 11, ISO 13485, and IEC 62304, while supporting audits and cybersecurity efforts.

Responsibilities

Drive end-to-end GAMP 5 validation lifecycle
Integrate AI-driven tools into quality management system
Lead audit support as software quality subject matter expert

Skills

Qualifications

BS in Computer Science or related field

About Personalis, Inc

personalis.com

Headquarters

Fremont, California, United States

Company Size

201-500 employees

Founded

2011

View Profile

Personalis is a genomics company transforming the active management of cancer through advanced ctDNA (circulating tumor DNA) technologies. Their solutions enable highly sensitive liquid biopsy testing, supporting applications from molecular residual disease (MRD) detection to therapy selection. Personalis serves oncology-focused customers seeking actionable cancer insights through cutting-edge sequencing and bioinformatics.