Quality Systems Specialist

Outset Medical(14 days ago)

Tijuana, MexicoOnsiteFull TimeMedior$67,862 - $92,344 (estimated)Quality

About this role

The Quality Systems Specialist supports, maintains, and continuously improves the Quality Management System for a medical device company. The role helps ensure compliance with global regulations and standards, with emphasis on ISO 13485 and FDA 21 CFR 820, and supports audit readiness. The specialist also monitors quality metrics and manages document control and training activities.

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Required Skills

Quality Systems
Document Control
Training
CAPA
Change Control
Auditing
Nonconformance
Metrics Analysis
ISO 13485
21 CFR 820

+2 more

Qualifications

Bachelor's Degree in Engineering/Medical/Science
Lead Auditor Certification (preferred)
Lean Six Sigma Training (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.