Job Title
Quality and Regulatory Compliance Supervisor
About Abbott
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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:
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 Youll 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
- Bachelors degree preferrable in Engineering or Health Sciences
- Desired Masters degree
Preferred Qualifications
Minimum of 8 to 10 years of experience in the field.
Intermediate English
- Medical devices knowledge
- SAP (QM Module)
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.
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The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
Required Experience:
Manager
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