• The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. • Primary focus will be on facilitating crossfunctional team process improvements, developing actions, and tracking, where needed, to meet defined objectives while satisfying regulatory requirements and business strategy. • Supports the development and implementation of the global regulatory FCA related requests for additional information communication process and activities. • Supports and monitors the completion of regulator requests for additional information to the US FDA, and other Regulatory Authorities as applicable. • Supports and contributes in cross functional teams on investigating, assessing and authoring responses. • Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements. • Gathers, collates, and maintains FCA AIR weekly report; distributes and presents to internal stakeholders. • Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner. • Escalates potential safety issues for risk assessment or health hazard assessment. • Supports and contributes the development of Global FCA AIR communications. • Works together with the Customer Quality organization to identify, access, and analyze data that have impact on the company's compliance with overall quality systems. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Advise management on potential improvements or enhancement to quality systems and processes in the company. • Develops new approaches to solve problems identified as part of the team. • Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required. • Participates in the CAPA process as required as an assignee or project team member. • Perform other duties as assigned.