Director of Quality

EPM Scientific; San Diego (CA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Equity and stock options

Comprehensive medical, dental, and vis

401(k) with company match

LTIP

Job summary

EPM Scientific seeks a Director of Quality for a leading medical device company in San Diego. You will guide the Quality function, ensure FDA/ISO compliance, and drive quality across development and post-market efforts.

The role requires strategic leadership, cross-functional collaboration with R&D, Regulatory, Manufacturing, and Operations, and readiness for FDA inspections and global audits. A high-growth, innovative environment awaits.

Qualifications

• Deep understanding of FDA QSR, ISO 13485, ISO 14971, and global medical device compliance.
• Experience in cardiovascular or Class III implantable medical devices.
• Expertise in design controls, risk management, CAPA, supplier quality, and process validation.
• Proven track record leading Quality teams through development, clinical studies, and regulatory inspections.
• Experience with product development, commercialization, and regulatory readiness.

Responsibilities

• Provide strategic leadership for the Quality Management System and regulatory compliance.
• Lead and mentor Quality Systems, Quality Engineering, Supplier Quality, Design Assurance, and Post-Market Surveillance teams.
• Collaborate with R&D, Regulatory Affairs, Clinical Affairs, Manufacturing, and Operations.
• Represent Quality during FDA inspections, Notified Body audits, and MDSAP audits.

Skills

FDA QSR

ISO 13485

ISO 14971

Quality Systems

CAPA

Design Controls

Process Validation

Supplier Quality

Post-Market Quality

Regulatory Inspections

Job description

EPM is partnered with a rapidly growing, mid-sized medical device company developing innovative cardiovascular technologies aimed at improving outcomes for patients with complex heart disease. With a strong commercial presence, a robust product pipeline, and continued investment in next-generation therapies, the organization is entering a pivotal phase of growth. As they scale manufacturing, expand globally, and advance new product development initiatives, they are seeking a Director of Quality to lead the Quality function and help shape the future of the organization.

Responsibilities:

• Provide strategic leadership for the Quality Management System, ensuring compliance with FDA regulations, ISO 13485, and international quality standards.
• Lead and mentor teams across Quality Systems, Quality Engineering, Supplier Quality, Design Assurance, and Post-Market Surveillance.
• Partner closely with R&D, Regulatory Affairs, Clinical Affairs, Manufacturing, and Operations
• Serve as the primary Quality representative during FDA inspections, notified body audits, and MDSAP audits.

Qualifications:

• Deep understanding of FDA Quality System Regulations, ISO 13485, ISO 14971, and global medical device compliance requirements.
• Prior experience within cardiovascular, structural heart, electrophysiology, neurovascular, or other Class III implantable medical device environments.
• Strong expertise in design controls, risk management, CAPA, supplier quality, process validation, complaint handling, and post-market quality systems.
• Demonstrated success leading Quality organizations through product development, clinical studies, commercialization, and regulatory inspections.
• Long-term incentive plan (LTIP), equity, and stock options
• Comprehensive medical, dental, and vision coverage
• 401(k) with company match
• Opportunity to make a significant impact within a high-growth, innovative medical device organization