Sr. Director, Corporate Auditing - Quality

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 Purpose:

This Quality Senior Director role leads and oversees the development, implementation, and continuous improvement of GetQMS, Getinge’s global Quality Management System in compliance with medical device regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820).

The Senior Director responsible for Corporate Auditing is a key leadership role responsible for overseeing the audit readiness processes of Getinge including direct responsibility for corporate audit support, corporate auditing, and the internal audit process through a Community of Practice model.

The position demands a strategic thinker with deep knowledge of the medical device industry and regulatory compliance. The Senior Director will partner with executive leadership and various departments to safeguard the company’s integrity, support operational excellence, and enhance stakeholder confidence.

Key duties and responsibilities:

• Strategic Leadership: In partnership with the SVP of Global QRC develop and implement GetQMS, Getinge’s Global QMS framework, and drive strategic initiatives. Lead the design, implementation, and maintenance of GetQMS to ensure compliance with global medical device regulations and standards with a special focus on both external and internal audit signals. Assesses health of system (compliance, efficiency, performance) by developing and monitoring key quality metrics and manages a portfolio of improvement actions/projects.
• Internal auditing: Work with the corporate and site internal audit teams to upgrade and improve internal auditing processes resulting in greater actional insights across the company.
• Management Controls: Working with the management controls caretaker continue to upgrade and improve the performance of the company’s management controls processes. Assesses health of system (compliance, efficiency, performance) by developing and monitoring key quality metrics and manages a portfolio of improvement actions/projects.
• Resource Management: Efficiently allocate and manage resources to optimize project outcomes. Provide leadership and mentorship to project management and Quality & Regulatory teams.
• Continuous Improvement: Drive a culture of continuous improvement by identifying areas for enhancement in quality processes. Implement best practices to enhance overall efficiency and effectiveness.
• Communication and Reporting: Upgrade and improve the quality of stakeholder communications. Effectively communicate strategy, updates, milestones, and challenges across Getinge to all stakeholders.
• Industry Engagement: Participates in industry & FDA conferences to stay informed on the latest trends, regulations, and best practices in auditing and compliance. Collaborate with senior leadership to assess and address emerging risks, industry trends, and regulatory changes.
• Responsible for the indirect development and management of personnel and programs in alignment with the project and activities needs.
• Build Quality into all aspects of Getinge work by maintaining compliance to the applicable quality requirements depicted in the GetQMS directives.
• Responsible for the leadership of Getinge’s quality auditing processes.  

Knowledge/Skills/Experience:

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• Master’s Degree in a relevant field (e.g., Business Administration, Quality Management, or other related science discipline or equivalent combination of education and experience is required).
• A minimum of 12 years related experience in the medical device field.
• Strong understanding of Quality Management System operations and application of the Regulations, ISO standards, and management controls.
• Experienced auditor with appropriate auditing certifications is required (e.g., ISO 13485, FDA 21 CFR Part 820).  FDA or Notified Body experience highly valued.

• Consent decree and remediation activities experience is preferred.
• Strategic QMS thinker with excellent analytical and problem-solving skills.
• Demonstrate ability to work collaboratively in a cross-functional environment.
• Effective communication and interpersonal abilities at all levels within the Getinge.
• Project Management experience required.
• IT skills related to operating various Microsoft and other systems.

The base salary for the position is a minimum of $220,000 and a maximum of $240,000 plus 35% in annual bonus. The position is eligible for a company vehicle. 

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.