Senior Quality Engineer

Outset Medical(8 days ago)

Tijuana, MexicoOnsiteFull TimeSenior$94,477 - $129,114 (estimated)Quality Engineering

About this role

A Quality Engineer at Outset Medical supports the company’s medical device quality system to ensure products meet regulatory and safety requirements. The role is part of the quality organization working across manufacturing sites to enable reliable product transfers and continuous improvement. The position contributes to data-driven management reporting and fosters a culture of compliance and performance.

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Required Skills

Process Validation
CAPA
Nonconformance
MRB
Sterilization
Cleanroom Manufacturing
Supplier Management
Failure Analysis
FMEA
Risk Analysis

+3 more

Qualifications

BS in Engineering
Lean Six Sigma
Quality Engineering Certification

About Outset Medical

outsetmedical.com

Outset Medical is a medical device company reimagining dialysis across care settings — from the ICU to the home. Its flagship Tablo hemodialysis system is a compact, integrated point-of-care platform that combines dialysis delivery, water management, and consumables to simplify setup and enable on‑demand treatments. Outset partners with hospitals, dialysis centers, and home-care providers to expand access, improve patient outcomes, and reduce operational burden through intuitive interfaces and cloud-enabled monitoring. Clinicians choose Outset for its emphasis on safety, ease of use, and more flexible, patient-centered dialysis delivery.