Medical Device Complaint Specialist

insulet; Región Centro; Presencial; MXN 320.000 - 520.000; Jornada completa

Descripción de la vacante

Insulet is seeking a Medical Device Complaint Specialist to evaluate, process, and investigate product complaints, ensuring regulatory compliance and timely resolution. You will perform complaint coding, reportability determinations, data analysis, and documentation reviews, collaborating with cross-functional teams to support quality objectives and continuous improvement.

The role requires strong analytical skills, attention to detail, and ability to manage multiple priorities in a fast-paced,

Formación

• High school diploma or technical or scientific discipline.
• Complaint handling experience preferred.
• 1-2 years data management, record keeping in Medical Device field.

Responsabilidades

• Analyze and process complaints promptly with proper coding and assessment.
• Assess vigilance reportability for moderate risk complaints using trees.
• Enter data and prepare reports/graphs for projects and lot qualification.
• Maintain accurate documentation and files for projects and complaints.
• Review lot documentation (DHRs) for anomalies related to failures.
• Process feedback letters and inform product support managers.
• Perform basic product review and initial failure analysis.
• Support investigation of potential adverse events.
• Assist in database development and reporting needs.
• Gather information during audits (FDA/ISO/internal).
• Lead projects aimed at improving complaint handling.
• Perform other duties as required.

Conocimientos

Verbal communication

Technical writing

Prioritization

Record keeping

Data management

PC skills

Ability to work under pressure

Educación

High school diploma or technical/scientific discipline

1–2 years data management experience in MedDev field

Complaint handling experience preferred

Herramientas

Word processing

Spreadsheet

Database

Data entry systems

Descripción del empleo

Job Summary

The Medical Device Complaint Specialist is responsible for evaluating, processing, and investigating product complaints to ensure accurate assessments, regulatory compliance, and timely resolution. This role supports complaint handling activities through complaint coding, reportability determination, data analysis, documentation review, device history record evaluations, and basic failure analysis. The position works closely with cross-functional teams to support quality and regulatory objectives, identify potential adverse events, maintain accurate records, and contribute to continuous improvement initiatives. Success in this role requires strong analytical and organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced, regulated medical device environment.

This position is integral to supporting the department through complaint handling, reportability determination, data analysis, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews, review, and closure of certain categories of complaints and work on complaint handling projects. It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks.

Responsibilities:

• - Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
• - Assess complaint vigilance reportability for moderate risk complaints, utilizing system based decision trees
• - Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification.
• - Maintain accurate documentation and files related to special projects, complaints and lot qualification.
• - Review and analyze lot documentation (DHR's) to determine if there are any anomalies that may have related to reported product failures.
• - Process feedback letters and communicate to product support managers for various reporting sites.
• - Perform basic product review and failure analysis.
• - Support investigation and review of potential adverse events.
• - Support database development and reporting capabilities related to the complaint / reliability department needs.
• - Assist in gathering information and data during FDA, ISO or other third party or internal audits, as requested.
• - Responsible for leading projects aimed at the continuous improvement of the complaint handling function.
• - Performs other duties as required.

Education and Experience/ Minimum Requirements:

• - High school diploma or technical or scientific discipline; and/or equivalent combination of education and experience.
• - Complaint handling experience preferred
• - Minimum of 1-2 years' experience in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.

Preferred Skills and Competencies

• - Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
• - Ability to organize and judge priorities.
• - Excels at generating and maintaining organized and accurate records.
• - PC skill, word processing, spreadsheet, database.
• - Able to work effectively in a high-stress, high-energy environment.
• - Able to make decisions quickly based on vague or imperfect information and evaluate the need to obtain clarification and direction when necessary.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!