.Quality Manager - Queretaro site in MexicoAbout 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 AbbottAt 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.Main Purpose Of the RoleThis position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. This individual develops and executes the required strategies and plans to improve product and process quality in order to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation where product is distributed. This position is responsible for collecting and documenting management review information, conducting regular meetings, and reporting the information to the plant's leadership team and the appropriate Divisional Management Representative.Main ResponsibilitiesManagement and development of applicable Quality department personnel.Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.Define and implement superior Process Control & Monitoring systems for critical process indicators throughout the product lines – Critical Parameter Management.Identify Quality Initiatives and lead cross-functional teams to complete them.Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.Oversee the facility's implementation of and compliance with Non-conformance and CAPA systems.Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance
