JOB DESCRIPTION:

Job Title

Quality and Regulatory Compliance Supervisor 

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 location in the Vascular Division.

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

What You’ll Do

Coordinate, ensure, control, and manage the documents and records that support the quality system processes.
- Analyze the quality system in place to identify quality deviations and / or recommending corrective and preventive actions, verifying its adequacy and implementation.
- Release or reject finished products and promotional materials that are received in the warehouse, evaluating compliance with the quality requirements.
- Develop, execute, and document training on procedures and policies for Abbott and 3PL personnel.
- Monitor the process of product handling, storage, and distribution to ensure AV quality policies and regulations requirements are met.
- Provide technical support to Abbott personnel and the third-party logistics operator 3PL in routinary activities related to the processes within the quality management system.
- Coordinate together with the One Abbott Colombia Team the audit / inspections process to the 3PL quality system.
- Ensure compliance with corporate requirements and local regulations in the processes of product return from customers to the 3PL, as well as the product destruction process and its final disposal.
- Conduct the execution of recalls, safety notifications, orrections, and removals (FSCA & Exception Escalation) or any issue with quality of the products distributed by AV Colombia.

Required Qualifications

- Bachelor’s degree, preferrable in Engineering or Health Sciences
- Desired Master’s degree

Preferred Qualifications

Minimum of 8 to 10 years of experience in the field.

Intermediate English
- Medical devices knowledge
- SAP (QM Module)

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:

No

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable