Medical Device Complaint Specialist

Location: Guadalajara, Jalisco, Mexico

Company

hirify.global develops the Omnipod wearable, waterproof medical device platform to support simpler and healthier lives for people with diabetes.

What you will do

• Analyze and process medical device complaints, including coding, assessment, closure, and timely documentation.
• Assess reportability for moderate-risk complaints using system-based decision trees and support potential adverse-event investigations.
• Review device history records and lot documentation to identify anomalies related to reported product failures.
• Prepare complaint, lot qualification, and special-project data, reports, graphs, and database updates.
• Perform basic product review and failure analysis, process feedback letters, and coordinate with product support managers.
• Support FDA, ISO, third-party, and internal audits, while leading projects to improve complaint-handling processes.

Requirements

• High school diploma or education in a technical or scientific discipline, or an equivalent combination of education and experience.
• 1–2 years of experience in data management, record keeping, and troubleshooting in the medical device field or a transferable technical and organizational role.
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a regulated, high-energy environment.
• Effective verbal and technical writing skills, with the ability to communicate across organizational levels.
• Proficiency with PC tools, word processing, spreadsheets, and databases.
• Ability to make timely decisions with incomplete information and identify when clarification is needed.

Nice to have

• Previous medical device complaint-handling experience.

Culture & Benefits

• Full-time role supporting an expanding medical device organization.
• Work is guided by shared values, customer focus, and performance-driven execution.
• Collaboration with quality, regulatory, product support, and other cross-functional teams.