Quality Systems Engineer in Minnesota

The Senior Quality Systems Engineer will ensure compliance with ISO 13485 and 21CFR 820 Quality System regulations. Oversee the Issues Management process including Corrective and Preventive Actions. Prepare quality metrics for management reviews and support data analysis with process owners. Actively participate in creating or improving QMS documentation, and ensuring solutions are implemented effectively. Lead internal audits, identifying non-conformances and areas for improvement as well as presenting the company to external auditors in a professional and knowledgeable manner. Ensure consistent change management and document control process execution and supporting peers. Lead Quality System software validation, support stakeholders with QS Enterprise software, and assist in evaluating and deploying new QMS software tools. Create and present professional training to cross-functional teams. Apply project management tools to complete tasks, identify obstacles, and ensure project...