Design Senior Quality Management Systems Engineer

We are seeking a Senior QMS Engineer to lead and enhance our Quality Management System, ensuring compliance across all operations and supporting continuous improvement initiatives.

This role plays a key part in maintaining audit readiness, driving quality processes, and ensuring company-wide adherence to regulatory standards.

What You’ll Do:

• Maintain and improve the Quality Management System (QMS)
• Lead internal and external audits (FDA, ISO, customer)
• Manage CAPA, nonconformances, and complaint processes
• Oversee document control, training, and quality system documentation
• Analyze quality metrics and drive continuous improvement

What We’re Looking For:

• 8+ years of quality experience in the medical device industry
• Strong expertise in QMS, audits, CAPA, and regulatory compliance
• Experience with ISO 13485, FDA 21 CFR Part 820, and quality systems tools
• Strong analytical, organizational, and communication skills