Senior Complaint Handler & QA Analyst (Medical Devices)

Baxter Healthcare; Tijuana; Presencial; MXN 300.000 - 520.000; Jornada completa

Descripción de la vacante

Baxter Healthcare in Mexico is seeking a Sr. Analyst, Complaint Hand to evaluate, process and investigate product complaints for Hill-Rom products to support post-market surveillance.

The Associate Analyst, QA must understand the customer’s allegation and accurately document the summary and investigation details as appropriate. You will work across teams to ensure accurate documentation, timely closure, and compliance with QSR, MDR, and ISO requirements, enabling quality improvements and patient

Formación

• Associate degree or 3+ years in medical devices.
• Proficient in spoken and written English.
• Strong written, verbal, interpersonal, analytical, and organizational skills.
• Experience resolving issues for internal and external customers.
• Able to meet deadlines and manage multiple projects.
• Some exposure to QSR, Medical Device Directive, ISO Quality System.
• Ability to define problems, analyze data, draw conclusions.
• Detail-oriented and accurate.
• Able to work as an individual contributor or in a team.
• Proficient with MS Office; familiarity with EtQ helps.

Responsabilidades

• Leads complaint operations within software applications.
• Handles sequencing of potentially reportable events within software based on risk.
• Ensures complaint records reflect the allegation, investigation and conclusion.
• Works independently and with different parts of the organization to resolve complex issues.
• Requests engineering review to identify root cause for malfunctions.
• Ensures timely closure of complaints to meet regulatory requirements.
• Supports audits by internal corporate, advised bodies, third parties, and regulators.

Conocimientos

Analytical skills

Organizational skills

Interpersonal skills

English (writing/speaking)

Problem solving

Educación

Associate degree

Herramientas

Microsoft Office

EtQ software

Descripción del empleo

Baxter Healthcare in Mexico is seeking a Sr. Analyst, Complaint Hand to evaluate, process and investigate product complaints for Hill-Rom products to support post-market surveillance.

The Associate Analyst, QA must understand the customer’s allegation and accurately document the summary and investigation details as appropriate. You will work across teams to ensure accurate documentation, timely closure, and compliance with QSR, MDR, and ISO requirements, enabling quality improvements and patient