Head of Quality Management Systems - Ultrasound

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Implements overarching quality mission and strategy, and ensures implementation of an open quality culture, for all assigned quality areas.

Acts as quality consultant for own organization.
The Head of Quality Management System (QMS) leads the global QMS organization for Ultrasound and is accountable for the design, governance, effectiveness, compliance, and continuous improvement of the Quality Management System across all business locations.

This leader ensures a globally harmonized, audit-ready, and efficient QMS that supports patient safety, regulatory compliance, business continuity, and operational excellence.

The role owns key enterprise quality processes including Document Management, Training Management, CAPA, Issue Investigation, KPI Management, and Process Governance while driving global standardization with effective local execution.

The position leads a geographically distributed team across the United States, India, South Korea (not disciplinary), Slovakia (not disciplinary).

Key Responsibilities

Quality Management System


* Own and continuously improve the global Ultrasound QMS framework.


* Ensure compliance with applicable regulations and standards, including FDA QMSR, ISO 13485, MDSAP, and EU MDR.


* Drive harmonized global processes and audit readiness across all sites.

CAPA & Issue Investigations


* Own governance of CAPA and Issue Investigation processes.


* Ensure timely, effective root cause analysis and corrective actions.


* Monitor systemic issues, trends, and process effectiveness.

Training Management


* Lead the global training and competency management program.


* Ensure employees are qualified and trained for quality-critical activities.


* Drive training effectiveness and compliance.

Document Management


* Own document control processes and eQMS (ETQ) governance.


* Ensure integrity, compliance, and efficient lifecycle management of QMS documentation.


* Simplify and standardize quality procedures globally.

KPI Management & Governance


* Define and maintain QMS KPIs and performance dashboards.


* Lead management review reporting and quality governance forums.


* Drive data-based decisions and continuous improvement initiatives.

Leadership


* Lead and develop a high-performing global team.


* Foster a culture of ownership, transparency, collaboration, and continuous improvement.

Qualifications


* Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.


* 10+ years of experience in Quality Management within the medical d...