Director, Quality Systems and Vigilance

Kardion•Irvine, CA

10d•Hybrid

About The Position

Kardion is a medical device company advancing innovative technology to improve patient outcomes. As we continue to scale our U.S. headquarters in Irvine and strengthen our global operating model, we are seeking a Director, Quality Systems and Vigilance to help build, mature, and lead critical quality systems that support compliance, audit readiness, and commercialization. The Director of Quality Systems and Vigilance will play a key leadership role in building and maturing Kardion’s global Quality Management System and Post Market Surveillance capabilities. This role will be based in Irvine and will partner closely with teams in both the U.S. and Germany. This is a hands-on, working Director role ideal for a leader who is equally comfortable setting direction and rolling up their sleeves to execute. The right candidate will bring strong Class III medical device experience, proven FDA inspection readiness leadership, and practical expertise in complaint handling, MDR, recalls, CAPA, and quality system development in a scaling environment.

Requirements

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
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.

Nice To Haves

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.

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.