Senior Quality Engineer

Outset Medical(6 days ago)

Tijuana, MexicoOnsiteFull TimeSenior$102,495 - $139,395 (estimated)Quality

About this role

Senior Quality Engineer at Outset Medical supports quality activities for design, development, and reliability of medical devices. The role ensures compliance with customer, risk management, quality, and Design Control requirements and maintains Design History File documentation and overall Quality System compliance. The position contributes to product transfers to manufacturing and supports post-market surveillance and supplier quality initiatives.

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Required Skills

Reliability Support
Risk Analysis
Design Control
Root Cause
Supplier Development
Verification
Validation
Statistical Analysis
DHF Documentation
FMEA

+5 more

Qualifications

Bachelor's Degree in Engineering or Science
Master's Degree Preferred
Certified Quality Engineer (Preferred)
Lead Auditor (Preferred)
Lean Certification (Preferred)

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.