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Analyst, QA (Complaints)

AbbVie

Analyst, QA (Complaints)

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

Job Description

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 RESPONSIBILITIESResponsible 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 trainingCarry out all other duties inherent to the position and those assigned by the immediate supervisor.

Locations

  • Heredia, H

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

70,000 - 95,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Complaint trending and analysisintermediate
  • Failure analysis and risk assessmentintermediate
  • Data presentation and reportingintermediate
  • Regulatory compliance and documentationintermediate
  • Communication and collaboration with cross-functional teamsintermediate
  • Record review and improvement identificationintermediate

Required Qualifications

  • Experience in medical device quality assurance, particularly with Breast Implants and Electromechanical Medical Devices (EMD) (experience)
  • Knowledge of regulatory compliance, Procedures, Standards, and Regulations in the medical device industry (experience)
  • Familiarity with Environmental, Health and Safety (EHS) requirements and internal policies (experience)

Responsibilities

  • Conduct complaint trending and product quality review, including evaluating complaints and failure analysis in Preventive Risk Assessments (PRA) for Breast Implants and EMDs
  • Review historical records of medical devices, document them in the system, and request required documents from personnel for DHRs and FIs
  • Identify opportunities for improvement in the review process of medical device records
  • Maintain communication with Post Market Quality Assurance department and Device Analysis Laboratory as needed
  • Host monthly Product Performance meetings to present product return data, complaint trending, and confirmed failure analysis
  • Support OMR preparation with DHR and DAL information
  • Ensure regulatory compliance and adherence to EHS requirements through policies, strategies, controls, communication, and training
  • Perform all other duties assigned by the immediate supervisor

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OperationsAbbViePharmaceuticals

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AbbVie logo

Analyst, QA (Complaints)

AbbVie

Analyst, QA (Complaints)

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

Job Description

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 RESPONSIBILITIESResponsible 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 trainingCarry out all other duties inherent to the position and those assigned by the immediate supervisor.

Locations

  • Heredia, H

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

70,000 - 95,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Complaint trending and analysisintermediate
  • Failure analysis and risk assessmentintermediate
  • Data presentation and reportingintermediate
  • Regulatory compliance and documentationintermediate
  • Communication and collaboration with cross-functional teamsintermediate
  • Record review and improvement identificationintermediate

Required Qualifications

  • Experience in medical device quality assurance, particularly with Breast Implants and Electromechanical Medical Devices (EMD) (experience)
  • Knowledge of regulatory compliance, Procedures, Standards, and Regulations in the medical device industry (experience)
  • Familiarity with Environmental, Health and Safety (EHS) requirements and internal policies (experience)

Responsibilities

  • Conduct complaint trending and product quality review, including evaluating complaints and failure analysis in Preventive Risk Assessments (PRA) for Breast Implants and EMDs
  • Review historical records of medical devices, document them in the system, and request required documents from personnel for DHRs and FIs
  • Identify opportunities for improvement in the review process of medical device records
  • Maintain communication with Post Market Quality Assurance department and Device Analysis Laboratory as needed
  • Host monthly Product Performance meetings to present product return data, complaint trending, and confirmed failure analysis
  • Support OMR preparation with DHR and DAL information
  • Ensure regulatory compliance and adherence to EHS requirements through policies, strategies, controls, communication, and training
  • Perform all other duties assigned by the immediate supervisor

Target Your Resume for "Analyst, QA (Complaints)" , AbbVie

Get personalized recommendations to optimize your resume specifically for Analyst, QA (Complaints). Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "Analyst, QA (Complaints)" , AbbVie

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score

Tags & Categories

OperationsAbbViePharmaceuticals

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No related jobs found at the moment.