The Opportunity This position works out of our Costa Rica location in our Vascular division. Our business purpose is to manufacture devices designed to optimize angioplasty procedures, including stents, diagnostic and imaging devices, catheters, guidewires, and vessel-closure devices.As the Quality and Compliance Manager position, you will be responsible for managing activities and areas that support the shared Quality Services within Abbott Vascular Costa Rica to ensure quality compliance, external audit readiness, risk management, batch release, and receiving inspection and CAPA program activities are executed and tracked by Abbott Quality System requirements and applicable regulations.Also, will provide leadership and guidance for the Quality Assurance and Compliance team and responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and vision, and standards and applicable regulations.What You'll Work OnResponsible for coordination, facilitation, and tracking of site management review meetings, quality data reviews and other operational quality reviews, preventive actions, and providing inputs on the Quality Management System effectiveness.Monitors compliance with company policies and procedures (e.g., compliance with FDA, EUMOR, ISO regulations, etc.).Maintain and implement necessary improvements to ensure site audit readiness for audits. Periodically evaluate and escalate compliance risks and coordinate remediation activities to ensure compliance with applicable requirements.Keeps the organization's vision and values at the forefront of decision-making and action.Develops and executes organizational and operational procedures and policies that affect one or more groups by utilizing technical/professional knowledge and skills.Builds strategic partnerships to further departmental and organizational objectives.Take initiative, gather data, and develop scenarios plans commensurate with risk.Demonstrates effective change leadership through continuous observation and aligns systems to drive ideal behaviors at all levels of the organization.Recruit, coach, reward, and develop diverse organizational talent.Foster a diverse workplace that empowers others to perform at their best by driving continuous improvement.Set a strategy that translates into actionable, aligned team goals.Provides direction and guidance to exempt specialists and/or supervisory staff. May supervise non-exempt employees.Manage administrative tasks related to overall resource management of the area under responsibility in collaboration with management.Bachelor's Degree in STEM related field.8+ years of experience in:Quality Systems and Lead Auditor.Develop, communicates, and builds consensus for operating goals that are in alignment with the division.Provides leadership to assigned staff and supervisors by communication and guiding towards achieving department objectives.Created immediate to long-range plans to carry out objectives established by top management.Make decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management; consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with a substantial expenditure of time, human resources and funds, and may jeopardize future business activity.Develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.Develops, communicates, and builds consensus for operating goals that are in alignment with the division. Provides leadership to assigned staff and supervisors by communication and guiding towards achieving department objectives.Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups; facilitates other's participation in the continuous improvement program; investigates and solves problems that impact work processes and personnel within or across units or departments; develops and communicates a vision for the organizational unit assigned.Provides direction and monitors the progress of exempt specialist and/or supervisory staff toward departmental goals, monitors costs of projects and human and material resources within a department.Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups; facilitates other's participation in the continuous improvement program; investigates and solves problems that impact work processes and personnel within or across units or departments; develops and communicates a vision for the organizational unit assigned.Auditor certification (preferred)
