As a Validation Engineer at Coloplast, I lead comprehensive validation processes, including IQ/OQ/PQ for equipment and software systems within an ISO 13485 environment. Collaborating with cross-functional teams, I ensure audit readiness by preparing, executing, and approving validation documentation, reviewing URS, FS, DS and P&IDs. I also own FMEA-based risk assessments for multiple Processes/Equipment, own validation-related NCRs and support Change Controls (CC). My goal is to contribute to process efficiency, quality improvement and be a Pioneer in bringing AI to Complex Manufacturing Processes. Plus, I have solid experience as Project Manager and Quality engineer within the Automotive Industry where I managed complex projects within the Kirchhoff Group, across 13 sites ( European Sites in: Poland, Germany, Hungary, Romania, Ireland, Portugal, Spain).
