Senior Quality Systems Engineer- Medical Electrical Equipment

Your responsibilities will include: Support Post Market reports to include PMVP, PMVR, PMSR, as well as other reports. Develop/document Quality Project Tracking Plans as well as Quality System Process Deviations Support internal and external audits and audit responses to existing products. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals. Experience with externals standards and regulatory requirements highly desired. Bachelor's degree in computer, electronic or electrical engineering 5+ years of experience in design assurance, post-market quality, or R&D engineering. Experience with electrical test and measurement equipment. Understanding and demonstrated use of IEC 60601 for medical electrical equipment Proficient use of Microsoft Teams, Word, PowerPoint, and Excel Experience in design engineering, process development and continuation engineering. Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise. Strong project management skills Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA). Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls.