Global Quality Systems Manager at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Global Quality Systems Manager in United States.

This role is responsible for ensuring the integrity, compliance, and continuous improvement of global quality systems within a regulated environment. The Global Quality Systems Manager maintains oversight of key quality processes, monitors performance metrics, and drives corrective and preventive actions to enhance system effectiveness. This position partners with cross-functional teams worldwide to strengthen compliance, optimize workflows, and support business objectives. The manager provides strategic guidance on audits, regulatory readiness, and quality documentation while ensuring alignment with ISO13485 standards. Success requires analytical rigor, strong organizational and communication skills, and the ability to influence teams across multiple geographies. The role includes up to 25% travel, both domestic and international, to support audits, inspections, and collaborative projects.

• Maintain, monitor, and improve quality system processes, including nonconformance management, logistics complaints, CAPA, internal audits, and planned deviations
• Review and approve quality records, ensuring accuracy, completeness, and regulatory alignment; escalate systemic issues and drive corrective actions
• Analyze quality performance metrics, present insights to leadership, and ensure actionable follow-up during management reviews and business meetings
• Oversee preparation and documentation of Management Review outputs, ensuring decisions and action items are clearly communicated
• Manage the annual internal audit program, including planning, execution, and verification of corrective actions
• Ensure ongoing compliance with ISO13485 and other applicable regulations, leading readiness activities for external inspections or audits
• Partner with global cross-functional teams to drive compliance and continuous improvement initiatives, enhancing quality system maturity and culture

Requirements:

• Bachelor’s Degree in medical device, life science, chemistry, or a related scientific discipline
• Minimum 7 years of experience in regulated quality systems within the medical device industry
• At least 5 years overseeing quality processes for third-party contract manufacturers or logistics operations
• Strong working knowledge of ISO13485 requirements and quality system principles; ISO13485 auditor certification preferred
• Demonstrated decision-making, analytical, organizational, and documentation skills
• Effective communication skills across multiple levels and functional areas
• Ability to manage multiple projects simultaneously while maintaining regulatory compliance
• Proficiency in Microsoft Office Suite and other relevant systems and tools
• Willingness to travel up to 25% for US and international engagements

Benefits:

• Competitive salary range of $120,000–$150,000 annually
• Health, dental, and vision insurance options
• Paid time off and flexible work arrangements
• Retirement savings and profit-sharing programs
• Professional development and training opportunities
• Supportive, collaborative, and inclusive work environment