Quality Complaint Analyst - Medical Devices

Outset Medical, Inc.; Tijuana; On-site; MXN 480,000 - 720,000; Full time

Job summary

Outset Medical, Inc. is seeking a Complaint Handling Specialist to execute and maintain the complaint lifecycle across the Tablo Hemodialysis System program.

You will work with Customer Support, Engineering, Service, and Medical/Clinical advisors to ensure accurate documentation, timely investigations, and compliant reportability. The role requires a Biomedical Engineering or related degree, 2+ years in medical devices, and strong knowledge of FDA QMSR/ISO 13485.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Biotechnology, or related field.
• Minimum 2 years in the medical device industry, preferably QA, Complaint Handling, or PMS.
• Working knowledge of FDA QMSR, ISO 13485, and U.S. regulatory requirements.
• Familiarity with FDA MDR (21 CFR Part 803) and complaint handling processes.

Responsibilities

• Contribute to continuous improvements of the Complaint Handling process.
• Provide information for timely Adverse Event reporting.
• Manage complaints through lifecycle with cross-functional teams.
• Assist with investigations, root cause analysis, and CAPA as needed.
• Ensure documentation and timely closure per procedures and regulations.

Skills

Analytical skills

Problem solving

Attention to detail

Quality Assurance

FDA QMSR

CAPA

Documentation

MS Office

eQMS

Education

Biomedical Engineering degree

Tools

Microsoft Office

eQMS

Job description

Outset Medical, Inc. is seeking a Complaint Handling Specialist to execute and maintain the complaint lifecycle across the Tablo Hemodialysis System program.

You will work with Customer Support, Engineering, Service, and Medical/Clinical advisors to ensure accurate documentation, timely investigations, and compliant reportability. The role requires a Biomedical Engineering or related degree, 2+ years in medical devices, and strong knowledge of FDA QMSR/ISO 13485.