Micro and Sterilization Lead

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.- More than 5 years related experience in a medical manufacturing industry preferably with a medical device background.- A good knowledge of Quality Management Systems, especially with document control regulatory requirements, preferably in a regulated environment such as medical devices industry.- You have a good knowledge of all aspect to cleanroom, around microbiological aspects of Biological indicators, and related microbiological concepts.- You are able to participate in audits and being audited.- You have experience working with Agile PLM system.- Very good knowledge in the areas of GDP, regulations, ISO 13485 standard and micro and sterilization processes.- Ability to work within a team and as an individual contributor in a fast-paced, demanding, and changing environment.- You have strong analytical skills, problem solving techniques and technical aptitude.- Ability to effectively communicate at multiple levels in the organization.- You have experience contributing to and implementing various process improvements.- You have strong organizational and proofreading skills as well as a very good attention to detail.**Work Environment**Ambu - a visionary and international workplace where your efforts matterAmbu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.This is a manufacturing facility and as a result, employees can be exposed potentially to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards