Senior Quality Engineer

Element Biosciences(1 month ago)

San Diego, CAOnsiteFull TimeSenior$104,000 - $137,000Quality Engineering

About this role

The Senior Quality Engineer at Element Biosciences will lead maturation of the Quality Management System toward ISO 13485 compliance and provide quality engineering expertise for on-market medical device products. The role partners closely with R&D, engineering, manufacturing, supply chain and commercial teams to drive quality, continuous improvement, and post-market activities. This San Diego-based, on-site position reports to the Manager, Quality Engineering and supports audits, regulatory compliance, and cross-functional quality initiatives.

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Required Skills

QMS
Calibration
Preventive Maintenance
Design Controls
Validation
Risk Management
Verification
DHF
DMR
DHR

+17 more

Qualifications

Bachelors Degree
ISO13485 Lead Auditor
ASQ CQE

About Element Biosciences

elementbiosciences.com

Element Biosciences is a genomics company that develops benchtop DNA sequencing systems, consumables, and analysis software. Its AVITI™ platform delivers high‑quality, scalable sequencing to help scientists move from inquiry to insight across research and translational applications. The company emphasizes simplified workflows, accessible instruments for labs of all sizes, and competitive cost‑per‑run. Element serves academic, biotech, pharma, and clinical research customers aiming to accelerate biological discovery and real‑world impact.