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We are searching for the best talent for Senior Manager, Strategic Projects Operational Readiness MedTech to be in San Jose, Costa Rica. Purpose: The Operational Readiness Manager is responsible for ensuring that all facility systems, processes, and personnel are fully prepared to support the start-up and ongoing operations of a medical device manufacturing facility.
This role coordinates cross-functional efforts to ensure compliance with regulatory requirements, efficient operational workflows, and readiness of all vital infrastructure.
Working closely with engineering, quality, safety, and operations teams, this role ensures that the facility meets operational, quality, and safety standards to support production in a highly regulated environment.
Responsibilities:Lead the development and implementation of operational readiness plans for new and existing facilities.Collaborate with project managers, engineering, and quality teams to develop schedules, timelines, and achievements for facility readiness.Ensure that all facility operations align with applicable regulations and standards, including FDA, ISO, and GMP guidelines.Manage site, facilities, maintenance, safety, and utilities operational readiness.Ensure accurate staff for GT/BT systems walkdown.Own and establish calibrations program for all utilities and facilities equipment.Own deployment of the MAXIMO system.Ensure creation of backup plan for preventing maintenance and Calibration Maintenance Management System to support all startup activities.Create and own all maintenance procedures for site operations.Own relationship of 'handoff' between FM and the business units. El anuncio original lo puedes encontrar en Kit Empleo: Kit Empleo
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