Analyst, QA (Complaints)
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Job Location:
Heredia - Costa Rica
Monthly Salary:
Not Disclosed
Posted on:
06-11-2025
Vacancies:
1 Vacancy
Job Summary
This role is responsible for complaint trending product performance quality presentation and complete Preventive Risk Assessment (PRA) for trend evaluation of complaints for Breast Implants and Electromechanical Medical Devices (EMD).
MAJOR RESPONSIBILITIES
- Responsible for complaint trending and product quality review which includes evaluating as reported complaints signals and conducting failure analysis on as analyzed complaint investigations in PRAs for Breast Implants and EMDs.
- Review the historical records of medical devices and document them properly in the system.
- Request the required documents from the appropriate personnel to carry out the review of DHRs and FIs.
- Support the process of reviewing the records of medical devices by identifying opportunities for improvement.
- Maintain constant communication with the Post Market Quality Assurance department to fulfill the requested requirements. Additionally communicate with the Device Analysis Laboratory if needed should any requirements arise.
- Host monthly Product Performance meeting to present product return data complaint trending and confirmed failure analysis.
- Support OMR preparation material for DHR and DAL info.
- Ensure regulatory compliance of activities carried out in the work area: applicable Procedures Standards and Regulations.
- Guarantee compliance with corporate and legal EHS (Environmental Health and Safety) requirements by adhering to internal policies and procedures. Likewise ensure compliance through the adoption of strategies internal controls communication and necessary training
- Carry out all other duties inherent to the position and those assigned by the immediate supervisor.
Qualifications :
- Bachelors degree in engineering (mechanical industrial electrical).
- English level at least B2 (C1 preferred)
- CQ
- E is a plus
- Microsoft Visio Power BI
- At least 3 years of experience in the medical device industry related to Quality activities preferably involving complaint handling and experience with electromechanical products.
- Valid US visa with at least 9 months remaining before expiration
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Anti Money Laundering
- JSP
- Law Enforcement
- Account Management
- ABAP
- Digital
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
