Quality Systems Specialist

Outset Medical

2 months ago

3.6 on Glassdoor

Tijuana, Mexico

Onsite

Full Time

Medior

2 applicants

View Job Listing

Apply to 100+ jobs

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.

Skills

Qualifications

Bachelor's Degree in Engineering/Medical/ScienceLead 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.