Director of Quality Compliance

Job Summary

A company is looking for a Director, Quality Systems & Compliance.

Key Responsibilities

• Lead the design, implementation, and continuous improvement of a unified, enterprise-wide Quality Management System (QMS)
• Develop and oversee the annual internal audit program and manage external audits/inspections
• Establish and report enterprise-level quality metrics and KPIs to support data-driven decision-making

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field
• 10+ years of quality and compliance experience in the medical device industry
• Deep understanding of FDA QSR, ISO 13485, MDSAP, EU MDR, and related global regulations
• Proven success in leading internal and external audit programs
• Experience in implementing or optimizing electronic Quality Management Systems (eQMS)