Global Quality Systems Manager (Remote US)

Getinge • Madison, WI

3d • $120,000 - $150,000 • Remote

About The Position

The Global Quality Systems Manager is responsible for maintaining, monitoring, and improving key quality system processes to ensure compliance with applicable regulatory requirements and standards, including ISO 13485 for Getinge’s global logistics operation. This role supports the organization by reviewing quality records, coordinating the collection and analysis of quality metrics, and ensuring effective documentation, reporting, and continuous improvement throughout the Quality Management System.

Requirements

• Bachelor’s Degree in medical device/life science/chemistry or other relevant science field.
• Minimum of 7 years of experience working in regulated quality systems within the medical device industry.
• Minimum of 5 years Quality experience oversight of 3rd party contract manufacturers and / or logistics Strong working knowledge of ISO 13485 requirements and quality system principles.
• Strong decision‑making skills with the ability to balance compliance requirements and business needs
• Strong analytical, organizational, and documentation skills.
• Ability to communicate effectively across functional areas and levels of the organization.
• Ability to develop and sustain positive relationships with global Getinge Logistics stakeholders.
• Ability to manage multiple projects simultaneously while ensuring regulatory compliance
• Proficiency using the MS Office Suite and other relevant systems and tools

Nice To Haves

• ISO 13485 auditor certification preferred.

Responsibilities

• Provide oversight and governance of QMS processes, including nonconformance management, logistics complaints, CAPA, internal audits, and planned deviations to ensure sustained compliance, operational continuity, and organizational readiness.
• Review and approve quality system records to ensure accuracy, completeness, and alignment with regulatory requirements and internal quality standards; escalate systemic issues and drive corrective actions as needed.
• Lead the development, analysis, presentation, and any resulting actions from quality performance metric analysis, ensuring actionable insights are generated and communicated during management reviews and business performance meetings.
• Evaluate quality data at a management skill and experience level to identify emerging trends, risks, and opportunities for process optimization; drive cross‑functional alignment and actions for improvement initiatives.
• Oversee preparation and documentation of Management Review outputs, ensuring clear communication of decisions, action items, and follow‑up activities across leadership teams.
• Manage and support the annual internal audit program, including risk‑based planning, resource coordination, execution oversight, and verification of the effectiveness of corrective actions.
• Ensure ongoing compliance with ISO 13485 and applicable quality system regulations, providing guidance to teams and leading readiness activities for external inspections or audits.
• Partner with Global cross‑functional leaders to drive compliance and improvement projects, leading initiatives that enhance QMS maturity, strengthen quality culture, and support business objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees