Head of Quality – Structural Heart Med Devices | Equity & Bonus

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 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.