Director, Quality Systems and Vigilance

Responsibilities

• Lead the design, implementation, and maturation of Kardion’s global Quality Management System in alignment with applicable regulatory and quality standards.
• Serve as a key leader for FDA inspection readiness, including inspection preparation, hosting, response coordination, and CAPA follow-through.
• Build and strengthen Kardion’s Post Market Surveillance capabilities to support U.S. PMA/commercial readiness and global post-market compliance.
• Oversee and improve processes related to complaint handling, investigations, Medical Device Reporting (MDR), recalls, field actions, and vigilance activities.
• Support compliance with U.S. and EU regulatory requirements, including MDR-related quality system obligations.
• Partner cross-functionally with Quality, Regulatory, Design, Supplier Quality, and other business leaders to ensure quality systems are scalable, practical, and aligned with business needs.
• Lead internal quality system improvements using data, trends, and post-market insights to strengthen organizational performance and compliance.
• Help define and build the future-state team structure for this function across the U.S. and Germany.
• Drive a strong culture of accountability, readiness, and continuous improvement across the quality organization.
• Support document control and broader quality system governance as needed.

Qualifications

• Bachelor’s degree in engineering, life sciences, or a related field.
• Director-level experience in Quality Systems, Post Market Surveillance, or a closely related quality leadership role within the medical device industry.
• Strong experience in Class III medical devices.
• Proven experience working in international/global organizations and managing across regions.
• Demonstrated success building, standing up, or maturing QMS systems in scaling companies, especially around the ~100 employee stage.
• Hands-on experience with FDA inspections and audits, including preparation, hosting, and follow-up.
• Strong working knowledge of:
• Quality Management Systems
• Complaint handling
• MEDDRA (Medical Device Reporting)
• Recalls and field actions
• CAPA systems and follow-through
• Strong understanding of U.S. medical device quality requirements and practical experience operating in a regulated environment.
• Ability to work as a true player-coach who can both lead and execute.

Preferred Qualifications

• Experience in cardiovascular medical devices.
• Experience managing or partnering closely with Document Control.
• Experience inheriting an existing quality system and maturing it for a growing organization.
• Familiarity with EU MDR requirements and post-market obligations.

Work Environment/Travel

• This role is based in Irvine, California and follows a hybrid schedule of 3 days in the office and 2 days working from home.
• Travel is expected to be approximately 20–30%, with the potential for increased travel during the first 6 months based on ramp-up and business needs, including travel to Germany.

Equal Opportunity Statement

Kardion is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, gender identity, sexual orientation, national origin, disability, age, or any other protected characteristic.

At-Will Employment

This position is at-will. Kardion or the employee may terminate the employment relationship at any time, with or without notice, and for any lawful reason.

Reasonable Accommodations

Applicants who require reasonable accommodation in the job application process may contact [email protected] to request assistance.

Why Kardion

Join a mission-driven team at the intersection of healthcare and technology. Kardion offers exposure to complex global accounting, opportunities for professional growth, and a culture rooted in integrity, collaboration, and innovation.