Quality Assurance Manager North Latam Vascular Division

Detalles de la oferta

.Quality Assurance Manager North LATAM Vascular DivisionQuality Assurance North LA Manager / Abbott Vascular Division / Medical DevicesLocation: Mexico CityAbout AbbottAbbott 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 AbbottCareer 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 OpportunityAs the Quality Assurance North LA Manager, you'll be responsible for complying with Abbott Vascular Quality Policy. You will plan, develop, and manage the Quality Assurance organization for Mexico and the North Latam Region to ensure overall compliance and effectiveness of the Quality System for the Vascular Commercial Affiliate. This includes management responsibility, purchasing controls, change management, document controls, product approval/marketing processes, production and process controls (P&PC), improvement (corrective action & preventive action-CAPA), and post-market support processes. You will operate under quality and regulatory directives and Abbott policies and procedures while following local regulations and international industry/quality system standards that apply. You will provide direction and guidance to team members, evaluate their performance, and assist in career development activities, ensuring that business objectives, budget, and quality metrics are met.What You'll Do:Establish and maintain an effective structure and organization to ensure consistent implementation of the Quality System for Abbott Vascular in Mexico & North Latam Region.Be responsible for quality system processes as SME: Supplier Controls and Evaluation, Distributor Management, Market Feedback and Product Experience Reporting, Field and Post-Market Communications, Documentation and Record Control, External Standards and Regulation Compliance, Ad/Promo Document Control, CAPA, Storage and Handling of Finished Vascular Medical Devices, Management Review, Change Control, Customer and Product Training.Monitor and ensure compliance with Abbott Policies, Procedures, and External Regulations and update Quality System accordingly.Oversee Quality System improvements and implementation projects.Drive continuous improvement of core processes to ensure quality is maintained while efficiency is optimized.Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance procedures are achieved.Coordinate audits by external bodies and ensure internal audit schedules are executed in a timely and effective manner


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