Director of Quality

EPM Scientific; Irvine (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Annual bonus

Equity LTIP

Medical, dental, vision

Job summary

EPM Scientific is partnering with a leading medical device company focused on breakthrough structural heart technologies. They seek a Director of Quality to lead the Quality organization across development, manufacturing, and post-market activities in Irvine, California.

The role drives QMS strategy, design controls, risk management, CAPA, and audits, reporting to executive leadership. You will mentor cross-functional teams and prepare for FDA inspections and global regulatory requirements.

Qualifications

• Bachelor's degree in Engineering or Life Sciences; advanced degree preferred.
• Extensive experience in structural heart or Class III implantable devices.
• Deep knowledge of FDA QSR, ISO 13485, ISO 14971 and global regulatory needs.

Responsibilities

• Provide strategic leadership for the Quality Management System and regulatory compliance.
• Lead Quality Systems, Quality Engineering, Supplier Quality, Design Assurance and more.
• Partner with R&D, Regulatory Affairs, Clinical Affairs, Manufacturing and Operations.
• Drive quality strategy across product lifecycle with design controls and post-market surveillance.
• Represent Quality during FDA inspections, notified body audits, and customer audits.

Skills

Quality leadership

Regulatory compliance

FDA regulations

ISO 13485

ISO 14971

Design controls

Risk management

CAPA

Audit management

Post-market quality

Education

Bachelor's degree in Engineering or Life Sciences

Advanced degree preferred

Job description

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