This position will oversee microbiological testing and environmental monitoring processes related to the development and manufacturing of Intravascular Ultrasound products at Philips. Responsibilities include managing routine environmental monitoring, product and water bioburden testing, compressed dry air sampling, microbial identification, and endotoxin testing for both products and water. **Your role:** * Supervise and executes changes in controlled documents for implementation of Micro Lab and QFI Projects. * Provides technical guidance to personnel on the best course of action to execute assigned tasks and responsibilities based on regulatory requirements and technical expertise. * Receives assignments in the form of objectives with goals and the process by which to meet goals. * Supervise, create and release validation process, equipment validation protocols and reports for projects. * Improves current process by developing best practices in the area. * Generates metrics for the area in order to improve process. * Developing professional expertise, applies company policies and procedures to resolve a variety of issues. * Lead CAPAs and NCRs process or other activity required for administration also execute GAP Analysis according to tha applicable standards. * Support and lead activities related NPI process related to calibration topics. * Develop and lead cost saving ideas and the Problem Solving for the Department **Minimum required Education:** Bachelor degree in Microbiology, Biology, Biotechnology Engineer, Chemical Analyst, Chemistry etc. **You're the right fit if:** + 5 + years of experience in the medical device industry or regulated industry and leading a team + Knowledge of statistical methods and the use of standard quality tools (e.g. flowcharts, Pareto charts, cause and effect diagrams, control charts). + Experience in document change control. + Knowledge in NCRs development + Knowledge of methodologies for inspection test tools is preferred + Advanced/Fluent English **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. **This is an administrative role.** **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.