**Job Description**:**Quality Manager****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 Costa Rica - Alajuela location in the Electrophysiology business unit. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.As the Quality Manager position, you will develop and executes the required strategies and plans to improve the quality of products and process assign in order to deliver planned business results and assure compliance.**What You'll Do**- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.- Keeps the organization's vision and values at the Forefront of decision making and action.- Demonstrate effective change leadership.- Builds strategic partnerships to further departmental and organizational objectives.- Interacts with internal and external customers, by meeting regularly, responding to request and explaining procedures.- Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO 13485, US 21 CFR 820 (QSR),EEO regulations, MDR, etc.) and proactively identifies improvement opportunities to assure compliance.- Management and development of applicable Quality department personnel.- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.- Proactively 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.- Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.- Oversee the facility's implementation of and compliance with Nonconformance and CAPA systems.- Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance and continuous quality improvement.- Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.- Prepare the department budget and salary plan revisions.- Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.- Prepare the department objectives for the fiscal year. This includes project plans, training, development, and other specific work plans.**Required Qualifications**- Bachelor's degree on an Engineering Science or Technical Field, or bachelor's degree in business administration.- 7+ years of experience in quality engineering roles:- **FDA Class II or Class III medical device experience.**:- ** Demonstrated extensive experience with Domestic and International **regulatory requirements and regulating bodies required**:- **Solid knowledge of and experience working with international quality **regulations, including US 21 CFR 820 (QSR) and ISO 13485.**:- **Demonstrated and impactful experience with product and process **qualification and validation, process improvement, lean and six sigma **methodologies, process control and monitoring (SPC).**:- ** Demonstrated results in nonconformance management and reduction, **value improvement, risk reduction, and cost containment.**:- ** Demonstrated organizational influence to include, but not limited to **compliance excellence, organizational improvement, product-related risk **mitigation, and/or manufacturing cost reduction.**:- **Ability to travel to support domestic and international manufacturing sites **(up to 15%).**:- ** Language Proficiency: Fully Bilingual (English and Spanish required)**:**Preferred Qualifications**- Master´s degree- 7+ years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.- FDA Class II or Class III medical device experience.- Quality or
