Senior Quality Engineer - Endoluminal Systems

📋 Description

• Oversee end-to-end quality investigations across manufacturing, supplier ops, design, and customer
• Lead cross-functional and cross-site quality investigations and audits.
• Own CAPA, Process NCs, risk assessments, and regulatory/compliance activities.
• Support regulatory and customer audits; interpret advanced quality data and KPI trends.
• Mentor junior engineers; ensure compliance with GMP, ISO, FDA standards.

🎯 Requirements

• Minimum 8 years QE/QA experience; engineering degree or equivalent.
• 2+ years in a regulated industry; experience supporting NPI and mechanical assembly of
• Strong data analysis, issue resolution, and cross-team collaboration.
• Experience with GMP, ISO, FDA; ability to lead quality improvements and risk assessments.