Quality Compliance Specialist

Job Summary

Working fully remote, the Commercial Quality Compliance Specialist will develop, execute, and oversee Quality and Compliance programs for the DePuy Synthes Sales Inc., focusing on distribution quality and timely resolution of quality-related issues while supporting orthopedic customers across the U.S.

Key responsibilities:

• Develop and manage Quality and Compliance programs for Distribution Centers and Loaner Distribution Points
• Serve as a liaison with Franchise Quality, Sales, and Supply Chain partners to address commercial quality matters
• Identify and implement quality and compliance improvement opportunities aligned with business objectives and regulations

Required qualifications:

• Bachelor's degree in regulatory compliance, science, or engineering with at least 2 years of experience in a regulated healthcare industry, or an Associate's degree with a minimum of 5 years of experience
• Knowledge of FDA regulations and ISO-13485 standards
• Experience in supplier quality management preferred
• Proven experience in a fast-paced, complex operation
• Experience interacting with Health Authorities or notified bodies preferred