Senior Director of Quality
Role: Senior Director of Quality
Location: San Diego, CA (On-site)
Salary: $190,000 - $250,000
EPM is partnered with a rapidly scaling, mid-sized medical device company operating at the forefront of structural heart innovation. This organization has built a strong reputation for advancing minimally invasive cardiovascular therapies, with a robust pipeline spanning next-generation catheter-based technologies and implantable systems. They are now looking to bring in a Senior Director of Quality. This is a critical leadership hire that will sit at the intersection of product innovation, regulatory strategy, and operational scalability.
Responsibilities:
- Provide strategic leadership over the company's Quality Management System, ensuring alignment with 21 CFR Part 820, ISO 13485, and global regulatory requirements.
- Lead and develop a growing Quality organization, including Quality Engineering, Supplier Quality, Quality Systems, and Post-Market Surveillance.
- Lead inspection readiness and act as a primary Quality representative during FDA and Notified Body audits.
Qualifications:
- Strong knowledge of applicable regulations and standards, including FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and global regulatory frameworks.
- Expertise in cardiovascular or structural heart devices is highly preferred, particularly within catheter-based, implantable, or minimally invasive technologies.
- Hands-on experience with key Quality processes, including CAPA, design controls, risk management, supplier quality, and post-market surveillance.
- Bachelor's degree in Engineering or a related technical discipline; advanced degree preferred.
Benefits:
- Competitive compensation package
- LTI's and stock options
- Medical, dental, vision insurance
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