Quality Engineer

Twist Bioscience(1 month ago)

HybridFull TimeMedior$89,634 - $119,315 (estimated)Quality Assurance

About this role

The Quality Engineer provides product quality engineering support across the product lifecycle for multiple platforms, with a focus on in vitro diagnostics and medical device environments. The role ensures compliance with 21 CFR 820, ISO 13485, EU IVDR and other applicable regulatory requirements while supporting cross-functional development, manufacturing, and field teams. The position also contributes to validation planning, supplier qualification, complaint and CAPA management, and quality system improvements.

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Required Skills

Batch Records
Data Analysis
Statistical Analysis
Quality Control
Product Release
Regulatory Compliance
CAPA Management
Complaint Handling
Risk Management
Supplier Qualification

+12 more

Qualifications

Bachelor's Degree in Scientific or Engineering Discipline

About Twist Bioscience

twistbioscience.com

Twist Bioscience is a San Francisco–based synthetic biology company that developed a proprietary silicon‑based DNA synthesis platform to produce high‑quality synthetic DNA at scale. It offers gene synthesis, oligo pools and pooled libraries, NGS target‑enrichment and exome panels, variant libraries, and related synthetic DNA tools. Twist serves research, diagnostics, drug discovery and industrial biotech customers, emphasizing high throughput, accuracy, and scalable manufacturing to accelerate genetic engineering, sequencing, and therapeutic development.