Head of Quality Management Systems - Ultrasound

Siemens Healthineers in; Issaquah (WA); On-site; USD 165,000 - 228,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers seeks a Head of Quality Management Systems for Ultrasound to lead the global QMS strategy and governance across sites in the US, India, South Korea, Slovakia. You will drive CAPA, training, document control, KPI governance and continuous improvement to ensure patient safety and regulatory compliance.

You will manage a distributed team, foster a culture of ownership and digital transformation, and ensure audit readiness across all locations with strong cross‑functional

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.
• 10+ years of experience in Quality Management within the medical device or other regulated industry.
• Proven leadership experience.
• Strong knowledge of CAPA, audit management, training, FDA regulations, ISO 13485, MDSAP, EU MDR and document control.
• Knowledge in Ultrasound devices and its accessories.
• Experience with eQMS platforms preferrable ETQ and quality data analytics.

Responsibilities

• Own and continuously improve the global Ultrasound QMS framework.
• Ensure compliance with FDA QMSR, ISO 13485, MDSAP, and EU MDR.
• Drive harmonized global processes and audit readiness across all sites.
• Own governance of CAPA and Issue Investigation processes.
• Lead the global training and competency management program.
• Own document control processes and ETQ governance.
• Define and maintain QMS KPIs and governance forums.
• Lead and develop a high-performing global team.

Job description

Head of Quality Management Systems - Ultrasound (Finance)

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

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 device or other regulated industry.
• Proven leadership experience.
• Strong knowledge of CAPA, audit management, training, FDA regulations, ISO 13485, MDSAP, EU MDR and document control.
• Knowledge in Ultrasound devices and its accessories.
• Experience with eQMS platforms preferrable ETQ and quality data analytics.

Leadership Profile

• Strategic and results-oriented leader
• Strong quality management expertise
• Global mindset with ability to influence across cultures
• Excellent communication and stakeholder management skills
• Passion for continuous improvement and digital transformation

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

The base pay range for this position is:

$165,490 - $227,546

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan.
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time.

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Siemens Healthineers is an Equal Opportunity and Aff

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