Director of Quality
Role: Director of Quality
Location: Irvine, CA (Hybrid)
Salary: $180,000 - $225,000
EPM is partnered with a rapidly growing medical device company focused on developing breakthrough structural heart technologies to address complex cardiovascular conditions. With strong clinical momentum, expanding commercial adoption, and a robust product pipeline, the organization is entering an exciting phase of growth. As they continue to scale operations, advance next-generation therapies, and expand globally, they are seeking a Director of Quality to lead the Quality organization and ensure excellence across product development, manufacturing, and post-market activities.
Responsibilities:
- Provide strategic leadership for the Quality Management System, ensuring compliance with FDA regulations, ISO 13485, ISO 14971, and global regulatory requirements.
- Lead and mentor teams across Quality Systems, Quality Engineering, Supplier Quality, Design Assurance, Manufacturing Quality, and Complaint Handling.
- Partner closely with R&D, Regulatory Affairs, Clinical Affairs, Manufacturing, and Operations to support product development and commercialization initiatives.
- Drive quality strategy throughout the product lifecycle, including design controls, risk management, process validation, supplier quality, and post-market surveillance.
- Serve as the primary Quality representative during FDA inspections, notified body audits, MDSAP audits, and customer audits.
- Support the development and launch of Class III implantable cardiovascular technologies while fostering a culture of continuous improvement and quality excellence.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
- Extensive experience within structural heart, cardiovascular, transcatheter valve, electrophysiology, or other Class III implantable medical device environments.
- Deep understanding of FDA Quality System Regulations, ISO 13485, ISO 14971, and international medical device compliance requirements.
- Strong expertise in design controls, risk management, CAPA, supplier quality, process validation, complaint investigations, and post-market quality systems.
- Proven success leading Quality organizations through product development, clinical studies, regulatory approvals, commercialization, and regulatory inspections.
- Demonstrated leadership experience building and developing high-performing Quality teams within fast-paced, growth-oriented medical device organizations.
Benefits:
- Competitive executive compensation package
- Annual performance bonus
- Equity participation and long-term incentive plan (LTIP)
- Comprehensive medical, dental, and vision coverage
- 401(k) with company match
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