Director of Quality

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. Annual performance bonus Equity participation and long-term incentive plan (LTIP) Comprehensive medical, dental, and vision coverage #J-18808-Ljbffr