Staff Quality Engineer Field Actions at Intuitive

Primary Function of Position The Senior Regulatory Compliance Program Manager for Product Issue Escalation-Recalls/Management Review will provide leadership for ISI’s quality systems function to ensure the overall quality management system (QMS) align with domestic and global regulatory requirements. Collaboration with business partners and management will be key to create and sustain a QMS infrastructure that is compliant, effective, efficient and agile to support a rapidly growing international business model with complex and diverse product lines. The Staff level person will have strong leadership skills to support established customer-focused quality initiatives plus technical product understanding to support continuous improvement and enable safety. The leadership skills will serve to manage projects that identify and drive continuous improvements for a robust and agile QMS. Essential Job Duties • Responsible for coordinate planning, scheduling, logistics and conducting product issue escalation meetings - recalls. • Provides guidance to SMEs for meeting requirements. • Works with Engineering, Quality and Operations teams as needed to ensure the information needed for the meeting is available. • Provides guidance to stakeholders in the interpretation of FDA regulations and external regulations/standards pertaining to assessing the need for field actions. • Responsible for documenting, tracking and obtaining approval and archival of the product issue escalation meeting , including attendance, meeting minutes, action items, and final decision. • Responsible for coordinate planning, scheduling, logistics and preparation for regional and executive Management Reviews, documenting, tracking and closing Action Items • Responsible for obtaining approval and archival of Management Review, including attendance, meeting minutes, action items etc. • Provides leadership for Quality Systems and Compliance projects and personnel to ensure the fulfillment of company quality goals and objectives • Mentors others for the development and maintenance of a robust quality systems and compliance team • Support facility inspections and audits required by government and regulatory agencies on a global basis. • Works with Audit Management on maintaining audit readiness for internal and external audits; provides backroom leadership during external audits • Performs assessments, develops action plans, and drives/facilitates implementation activities to address new requirements from global standards or regulations • Supports business partners and QSC group in determining risk-based actions and decisions to ensure quality system issues are appropriately escalated and addressed • Develops, maintains and improves processes and procedures for various processes within the quality management system and where necessary, provides training • Collaborates with OUS ISI sites in the harmonization of primary quality system processes and where appropriate, leads primary quality initiatives within the quality systems