Robotics and Digital Surgery, a division of Johnson & Johnson Medtech Surgery Group, seeks a Head of Quality and Compliance for the Monarch platform. The role oversees Design & Development, Manufacturing/Operations, Quality & Compliance, and Post Market Surveillance, reporting to the Global VP of Q&C Robotics and Digital Surgery at the Santa Clara campus in California. This role is responsible for overseeing Quality and Compliance, with a focus on product design, manufacturability, and reliability throughout Product Development, Operations, Distribution, and Commercial processes. The position involves collaboration with teams including quality associates, engineers, and managers, who carry out product quality and compliance tasks across areas such as risk management, product design, manufacturing process and technology development, product verification and validation, large-scale manufacturing, supplier management controls, quality control and compliance, post-market surveillance, project planning and transformation, and related Quality Management System activities. The Head of Monarch Q&C partners with cross-functional teams to drive product innovation and meet customer needs. They lead the Monarch Quality & Compliance team, maintain a scalable QMS, and collaborate with the Global VP Q&C Robotics on strategy and growth. Key duties also include overseeing audits, CAPA management, post market surveillance, and quality KPIs, while improving processes for reliability and scalability. Sr. Director, Quality & Compliance; Monarch Platform will: Collaborate with Monarch platform business leaders to formulate business strategies and ensure that organizational objectives, strategies, and quality standards are consistently aligned. Focus on implementing Quality Management System policies to meet customer safety, satisfaction, and regulatory requirements. Emphasize benchmarking and the dissemination of best practices both within Johnson & Johnson and externally to enhance organizational competitiveness. Work with Operations and Process Excellence to drive customer improvements by aligning risk management, process transformation, and business priorities. Build and strengthen Quality and Compliance skills, focusing on technology expertise and leadership with full accountability. Help define the strategy for quality and compliance, aligning customer and market needs with product development and manufacturing to meet Monarch platform and Robotics business goals. LEADERSHIP EXCELLENCE Acts as a Strategic Integrator—connecting quality strategy with product innovation, manufacturability, and business outcomes. Demonstrates Transformational Leadership—able to scale organizations, implement accountability models, and elevate quality as a competitive advantage. Serves as a trusted Enterprise Influencer, collaborating across J&J MedTech and external agencies to drive proactive compliance and regulatory engagement. Embodies Proactive Risk Leadership by identifying and mitigating potential compliance or design risks early in the development cycle. Leads with technical credibility and executive presence, inspiring confidence across engineering, operations, and executive teams. Builds and mentors high-performing quality teams, fostering empowerment, cross-functional collaboration, and continuous improvement. Manage influence, collaboration, and leadership of cross-functional teams to reach risk-based decisions in complex capital medical device product reviews. Uses analytical skills and innovative Quality Engineering methods to solve problems and meet business goals. Demonstrates a strategic and goal-oriented approach in formulating and implementing mid to long term functional strategies and transformational initiatives. Show leadership and team development skills in line with Johnson & Johnson’s Credo. Lead the development and implementation of top-tier quality management and engineering systems to support product life cycle management, emphasizing early defect prevention and detection for optimal customer satisfaction. Promote collaboration and knowledge sharing among product development, operations, manufacturing, contract manufacturers, and suppliers. Mentor engineers and leaders across R&D, New Product Development, and Operations to build and maintain a robust talent pipeline. Show understanding of both current and developing regulations and practices to assist clinical research teams in first-in-human studies, as well as meet the requirements for sponsors involved in clinical investigations of medical devices. Collaborate with quality and regulatory teams to maintain compliance with current international quality systems and product standards, including requirements related to human factors, cybersecurity, and product security. Assist with regulatory submissions by analyzing data, interpreting requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA, EU MDR, and other relevant regulations. Collaborate with Johnson & Johnson teams to implement standard processes across Robotics. Ensure that Quality and Compliance are involved as partners, provide guidance in developing talent, maintain trust, share accountability, and apply best practices to enhance competitiveness.