Job Title
Gerente de Calidad para Colombia y DX countries
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 Bogotá site location in the Diabetes division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.
We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
What You'll Do
Ensure that Abbott Diabetes Care Colombia quality programs defined and are established according to the policies and procedures of quality assurance of the international division and the existing local regulations.
Support to the Division to provide quality compliance in field and ensure the implementation of policies and procedures.
Report problems of noncompliance with quality management and regulatory.
Monitor local regulations that impact of the business.
Report commercial QA/RA with changes in responsibilities and contacts.
Ensure compliance with local & International laws, policies and quality and regulatory programs of the company.
Main contact before the health authority on issues of medical devices of the affiliate.
Generates technosurveillance and reactionsurveillance reports within the times established by the regulatory entity.
Provides a timely response to requests from the health authority. Monitor and evaluate the impact of emerging regulations of the country.
Establishing, implementing, and maintaining the quality management system at the Commercial Affiliate site to follow Abbott Quality and Regulatory (AQR), Division, and local regulations, processes, and procedures.
Ensuring compliance with the applicable ADC divisional procedures and any applicable external standards and regulatory requirements.
Managing the retention schedule of quality records under consideration of local legislation and Abbott requirements.
Conducting management reviews will be conducted in accordance with ADC divisional procedures.
Communicate to ADC Regional Quality Assurance events deemed significant from a compliance, regulatory, quality, product supply, or safety perspective. Create and maintain an organization chart of Affiliates.
Ensure job descriptions with minimum requirements for all functions are established, maintained by the manager, and approved by human Resources Department, functional or business manager.
Maintain the traceability of the products entered the country from their importation to their commercialization. Responsible for selection, evaluation, approval and control of suppliers and distributors for all activities performed for distribution of ADC and ADC branded products in the applicable country or region.
Approval of promotional material in Veeva to comply with local regulations and divisional policies.
Ensure that ADC products are handled, stored, maintained, and distributed in accordance with ADC requirements and product labeling.
Ensure ADC product handling and storage processes and requirements are followed within the Abbott affiliate warehouse and staff are trained to meet appropriate requirements.
Communicate any changes to product labeling of ADC and ADC branded products that could impact product registration within the applicable region or country to the Commercial Affiliate.
Ensure that contracted external warehouses know Abbott's processes and requirements and are regularly trained on them. Perform documented processes to place a product on quality hold, stop shipment, and comply with an ADC Field action.
Responsible for initiating and implementing any site related corrective actions per the applicable divisional and/or Abbott procedures for Corrective and Preventive Actions for Commercial Affiliates, as well as complying with any requirements in applicable local procedures.
Approval and final disposition of product returns. Management of field actions, quality holds, stop shipments.
Coordinate with the Colombian foreign trade area, the shipment of the products required for Investigation in Alameda.
Support the LATAM Call Center with special request and elevations of calls in Colombia.
#J-18808-Ljbffr
