.Business Area: QA/RA- Location: Ciudad Juárez, MX- Country: Mexico- Employment type: Full-time**A key role within the organization by leading the micro and sterilization processes**Do you want the chance to provide support to the organization as well as impact product development? Do you want to work in a dynamic organization where every day is different from the other? At Ambu, you will work closely with your local and international colleagues from Denmark and Asia, but also from the US.As a **Micro and Sterilization Lead**, you will be responsible to lead, administrate and coordinate the sterilization services. In addition, you will lead sterility assurance programs in accordance with established, approved specifications and procedures as well as release products for distribution upon certifying sterility results. You will have the responsibility to manage the sterilization and retention sample programs.**Your main objectives will be about**- The sterilization release of Ambu A/S products.- Establishing and monitoring rules and regulations for behavior in the cleanroom environment.- Managing the quality risk by stopping or putting on hold the production as necessary.- Rejecting to sterilization release of product/lot and escalate any problems to NCR/CAPA.- Making NCR's, CAPA's and SCAR's following our existing procedures.- Leading the overall activities related to microbiology tasks for cleanroom validation and monitoring.- Analyzing and evaluating the sterilization studies data and assisting in the preparation of documentation using Good Documentation Practices (GDP).- Preparing, controlling and disposing required materials to monitor the environmental condition of cleanroom to follow applicable standards.- Leading small project teams as needed to accomplish project objectives.- Managing and controlling external suppliers for monitoring.- The responsibility for the logistic of samples to be tested, including but not limited to bioburden test samples and biocompatibility test samples.- Playing a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and time scale management.- Designing and performing Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical device.- Recommending techniques to improve existing products/processes and process controls.- Defining alert and action levels on cleanroom based on historical data.- The responsibility for the review of certification of sterilization and release of product, procedures regarding sterilization releases, sterilization validation, cleaning in the cleanroom and training.- The responsibility for the cleanroom monitoring and re-evaluation process.- The responsibility for being the site representative for the micro and sterilization department during audit.**Your background**- You have at least a bachelor's degree preferably or related technical field