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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
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.