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