Quality Complaint Analyst

Outset Medical(7 days ago)

Tijuana, MexicoOnsiteFull TimeJunior$61,783 - $83,116 (estimated)Quality

About this role

Responsible for executing and maintaining the product complaint handling process, managing complaints through their full lifecycle from intake to closure. Works with cross-functional partners to ensure accurate documentation, timely investigations, and appropriate reportability assessments in accordance with regulations and company procedures. Supports continuous improvement of complaint handling and related Quality System activities.

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Required Skills

Complaint Handling
Adverse Reporting
Investigation
Documentation
Stakeholder Management
Regulatory Compliance
ISO 13485
ISO 14971
GMP
MS Office

+3 more

Qualifications

Bachelor's Degree

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.