Site Head, Quality — Medical Devices & Regulatory Leadership

Link-Worldwide is seeking a Site Head, Quality for its Tijuana manufacturing site. This crucial role oversees the Quality Management System to ensure compliance with FDA regulations and international standards for Class II medical devices, ensuring patient safety and scalability.

The ideal candidate has over 10 years of quality leadership experience in the medical device industry, a strong background in FDA 21 CFR Part 820, and proven skills in leading QA teams. This position champions continuous improvement initiatives and manages regulatory inspections effectively.