Senior Director of Quality

Responsibilities

• Provide strategic leadership for the company's Quality Management System, ensuring compliance with FDA regulations, ISO 13485, and global regulatory requirements.
• Led 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