Director of Quality

Role: Director of Quality

Location: San Diego, CA (On-site)

Salary: $180k - $250k

EPM is partnering with an innovative medical device company developing cutting-edge wearable and connected technologies that are helping transform the management of chronic conditions. As the organization continues to scale, they are seeking a Director of Quality to lead and evolve the Quality function across product development, manufacturing, and post-market activities.

Responsibilities

• Lead and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements.
• Partner with cross-functional stakeholders across R&D, Regulatory Affairs, Manufacturing, Operations, and Supply Chain.
• Drive Design Assurance activities throughout the product lifecycle, including risk management, verification, validation, and design transfer.
• Oversee CAPA, complaint handling, nonconformance management, internal audits, supplier quality, and post-market surveillance.
• Lead Quality strategy during product development, commercialization, and organizational growth.
• Support regulatory inspections, notified body audits, and customer audits.
• Build, mentor, and develop a high-performing Quality team.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 10+ years of Quality experience within the medical device industry.
• Prior leadership experience managing Quality teams and cross-functional initiatives.
• Strong working knowledge of FDA Quality System Regulations, ISO 13485, CAPA, risk management, and Design Controls.
• Experience supporting Class II and/or Class III medical devices.
• Experience within wearable devices, diabetes technology, connected devices, digital health, or combination products is highly preferred.
• Demonstrated success supporting products from development through commercialization.

Why This Opportunity?

• Join a rapidly growing organization in a high-growth market.
• Play a key role in bringing innovative wearable technologies to patients.
• Influence Quality strategy at both the operational and executive levels.
• Competitive compensation, bonus, equity, and comprehensive benefits package.