Director, Global Quality Systems Strategy (Remote US)

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

 

The Director of Global Quality Systems Strategy is responsible for the strategic leadership and continuous improvement of Getinge’s global Quality Management System (GETQMS) and performance oversight processes. This role ensures quality system effectiveness, regulatory compliance, and simplification across global entities by driving cross-functional collaboration, standardization, and transparency in quality performance. The Director also leads strategic initiatives in management controls and quality planning, ensuring that quality metrics and improvement initiatives are aligned with organizational goals and evolving regulatory expectations.

 

 

Job Responsibilities and Essential Duties

 

• Own the strategy and execution of GETQMS as a key enabler of product and process quality across Getinge’s global operations.
• Ensure the GETQMS framework is compliant, effective, and continuously optimized for efficiency and business integration.
• Assess and monitor the health of the system (compliance, performance, and user adoption) and lead a portfolio of QMS improvement initiatives.
• Lead a global Quality Management System Community of Practice to share best practices, maintain consistency, and drive innovation.
• Lead the design, implementation, and evolution of a robust global Management Controls framework that aligns with Getinge’s strategic objectives.
• Define and oversee key performance indicators (KPIs) for quality, collaborating with Quality, Sales and Service, and Site leaders to ensure accountability and visibility.
• Facilitate the Management Review process as a strategic tool to drive cross-functional alignment and inform executive-level decision-making.
• Drive continuous improvement by aligning quality planning with strategic initiatives and operational needs.
• Act as a central liaison between Corporate Quality, local quality teams, and key business stakeholders to ensure harmonized quality practices.
• Champion a culture of quality by embedding compliance, risk awareness, and performance ownership into operational routines across the business.

 

Required Knowledge, Skills, and Abilities

 

• Bachelor’s Degree in a relevant discipline (e.g., Quality Management, Engineering, Life Sciences, or Business Administration), or equivalent combination of education and experience.
• Masters Degree preferred
• A minimum of 10 years of progressive experience in quality systems and compliance within the medical device or life sciences industry, including leadership of cross-functional teams.
• Proven expertise in the implementation, governance, and continuous improvement of global Quality Management Systems.
• In-depth understanding of applicable regulatory frameworks (e.g., FDA QSR, ISO 13485, EU MDR), quality risk management, and management controls.
• Demonstrated experience leading successful regulatory inspections, remediation activities, or operating under consent decree conditions.
• Industry certification in quality or regulatory affairs (e.g., Six Sigma, CQM/OE, ISO Lead Auditor) preferred.

• Strategic systems thinker with strong business acumen and the ability to align quality system execution with enterprise goals.
• Skilled at building collaborative relationships across global, matrixed organizations and driving influence without direct authority.
• Excellent written and verbal communication skills, with the ability to present complex quality topics to executives, regulators, and cross-functional teams.
• Strong project management capabilities with a track record of leading large-scale system or process transformations.
• Proficient in data