Gerente de Calidad para Colombia y DX countries

Job description

JOB DESCRIPTION: Job Title Quality Manager for Colombia and 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, Colombia location in the Abbott Diabetes Care (ADC) división As the Quality Manager Colombia & Medical Device Technical Director, you will be responsible for ensuring that the Quality Management System complies with Abbott Quality & Regulatory (AQR) requirements, divisional procedures, local regulations, and applicable international standards. Additionally, you will serve as the Technical Director for Medical Devices before INVIMA, providing regulatory oversight and ensuring compliance throughout the product lifecycle, from importation and storage to distribution and post-market surveillance. What You’ll Do Support to the Division to provide quality compliance in field and ensure the implementation of policies and procedures. Report problems of non-compliance 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 techno-surveillance and reaction-surveillance 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. Monitoring 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 and/or UK. Support the LATAM Call Center with special request and elevations of calls in Colombia Work with the Quality Representative of in the implementation and management of the Quality Management System for this region Be the Technical Director for medical devices before Competent Authority (INVIMA) including among others the following responsibilities: Provide technical advice to the legal representative regarding the characteristics of medical devices, as well as meet the requirements of current regulations regarding their quality. Support the company's supplier and distributor selection process, participate in the structure of the purchasing processes of imported medical devices and in advising third parties to achieve compliance with the technical and regulatory requirements of medical devices. Ensure that the stored medical devices are in the established conditions and the documentary support and respective records exist. Approve the procedures related to the storage, packaging, dispatch and distribution operations of medical devices. Ensure that permanent staff training is carried out and that it is adapted to needs. Verify that storage and/or conditioning and distribution records are completed at each stage of the process. Guarantee the maintenance of storage and/or conditioning areas and, in general, the facilities. Ensure that proper process checks and calibrations of control equipment and instruments are carried out, as well as that these checks are recorded and that the corresponding reports are available. Guarantee, through monitoring and control, the traceability of the medical devices for compliance with the surveillance programs. Be responsible of the procedures for complaint handling and removing medical devices from the market, as well as the monitoring of adverse incidents that occur and their reporting to the health entity. Monitor compliance with the provisions established in Resolution 4002 of 2007. Be responsible for the inspection and/or preparation activities of medical device. Be responsible for keeping the quality of medical devices before the health authority Required Qualifications Bachelor’s degree in following disciplines: Biomedical Engineering, Medicine, Dentistry, Bacteriology, Chemistry, Chemical Engineering Preferred Qualifications 4+ years of experience in Quality Assurance and Regulatory Affairs within the medical device, diagnostics, healthcare, pharmaceutical, or life sciences industry. Intermediate English proficiency (written and verbal). Previous experience serving as a Technical Director, Quality Manager, or Regulatory Affairs professional within the medical device or healthcare industry. Knowledge of international quality standards and medical device regulatory frameworks. Experience managing suppliers, distributors, and third-party logistics providers. Strong leadership, stakeholder management, communication, and cross-functional collaboration skills. Experience working within multinational organizations and matrix environments. Apply Now Follow your career aspirat