You will lead a team of quality engineers to ensure that products meet quality goals, and regulatory requirements including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and risk management per ISO 14971. You will handle defining and implementing standard operating procedures to meet regulatory requirements while leading risk management activities in relation to design and production changes, and issues discovered during testing, and in the field. You will also focus on:• Partnering with the post-market surveillance team and external partners to drive improvements for sustaining products• Ensuring the execution of systems which identify and resolving quality issues (CAPAs)• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues• Ensuring the investigation, resolution and prevention of product and process non-conformance• Providing support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.• Identifying quality improvement initiatives in support of QMS and other regulatory requirements.• Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.Additionally, cross-functional communication skills and experience are crucial to success in this role. You will interact with all engineering design disciplines and project management teams, and will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams.