Senior Director of Quality
Role: Senior Director of Quality
Location: South San Francisco, CA (On-site)
Salary: $190,000 - $250,000
EPM is partnered with a rapidly scaling, mid-sized 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
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