Senior Director of Quality

Role Senior Director of Quality Location South San Francisco, CA (On-site) Salary $190,000 - $250,000 Company Overview EPM is partnered with a rapidly scaling, mid-size medical device company operating at the forefront of surgical robotics innovation. This organization has established itself as a leader in advanced robotic-assisted technologies designed to improve procedural precision, clinical outcomes, and patient recovery. With multiple commercial products and a strong development pipeline, the company is entering an exciting phase of growth and is seeking a Senior Director of Quality to help drive quality excellence across the organization. This is a critical leadership hire that will sit at the intersection of product development, regulatory strategy, and commercial scale-up. Responsibilities Provide strategic leadership for the company's Quality Management System, ensuring compliance with FDA regulations, ISO 13485, and global regulatory requirements. Lead and develop a growing Quality organization across Quality Engineering, Quality Systems, Supplier Quality, Design Quality, and Post-Market Quality. Partner closely with R&D, Manufacturing, Regulatory Affairs, and Operations. Drive inspection readiness and serve as the primary Quality representative during FDA inspections, ISO audits, and international regulatory assessments. Establish and enhance quality metrics, risk management practices, and continuous improvement initiatives to support commercial growth and product innovation. Qualifications Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and global medical device regulatory requirements. Prior experience within surgical robotics, capital equipment, robotic-assisted surgery, or other highly complex electromechanical medical devices. Demonstrated expertise in design controls, risk management, CAPA, supplier quality, process validation, and post-market quality systems. Proven experience leading quality organizations through product development, commercialization, and regulatory inspections. Bachelor's degree in Engineering or a related technical discipline; advanced degree preferred. Benefits Competitive compensation package LTI's and stock options Medical, dental, vision insurance #J-18808-Ljbffr EPM Scientific