Hiring: Director of Quality Company: EPM Scientific Location: San Diego, CA Job Posted Time: 2026-09-10 13:52:14 Employment Type: On-site Target Skills & Keywords : R, Risk Management About the job Required Skills: •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: •Comprehensive expertise in 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. Compensation: •$190,000 - $225,000 / year •Long-term incentive plan (LTIP), equity, and stock options Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!