JOB DESCRIPTION:

Job Title

Analista Senior de Calidad y Cumplimiento Regulatorio SLA

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of .
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Bogota in the division Vascular and Structural Heart.

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Structural Heart Business Mission:  why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

What You’ll Do  

Interact and communicate with Sales Reps and Distributor contacts to ensure timely PER submission and responses to Request for Information (RFI).
-    Prepare and submit serious adverse event and quarterly reports to regulatory authorities according to post-market surveillance regulation.  
-    Close follow-up and communication with the Product Performance Group (PPG) to obtain PERs analysis information and guarantee accurate understanding of data provided in Spanish by Sales Reps. and Regional Distributors contacts.
-    Collection, analysis and reporting of applicable KPI to upper management and distributor’s representative in a periodic basis.
-    Coordinate and ensure the prompt return of devices involved in PERs for investigation and analysis.   
-    Maintain and update South and Central LATAM AV and SH PERs databases to provide information to Regulatory Authorities and stakeholders in a timely manner.   
-    Support the process of non-conformities identification and corrective and preventive actions (CAPA) implementation to pursue the Quality System continuous improvement.
-    Perform control of South and Central America Distributors processes to confirm compliance with Abbott and Divisional policies and procedures.
-    Contribute to the Quality Management System (QMS) documents creation, review and update to comply with the defined requirements and optimize processes.
-    Support the product approval and sales release process.
-    Execute Quality Control tasks as a member of the SLA Quality Team
-    Support activities for Quality Improvement Projects by executing tasks as assigned or follow-up on actions in Quality Plans.
-    Ensure training compliance within SLA region related to product experience handling, through on-line trainings.
-    Support CALA QS Manager with monthly & quarterly consolidation of Key Performance Indicators (KPI) as indicated on the LS608 Quality System Metric Definition. In addition, active participation at the Division COMQA Escalation review. The responsibilities will be carried out temporarily until the return of CALA Sr. QA Analyst.

Required Qualifications

Bachelor’s degree Biomedical Engineering, Pharmaceutical Chemistry, Industrial engineering, or related areas

Preferred Qualifications

-  3 year of experience

- Fluent in English
- Técnica knowledge on medical devices and equipment
- Teamwork 
-  MS Office
-  Power BI   

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Quality Assurance

     

DIVISION:

AVD Vascular

        

LOCATION:

Colombia > Bogota : Building II

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable