Senior Supplier Quality Engineer

About the Company

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

Responsibilities

• Develop and maintain quality systems, processes, and procedures related to supplier quality management
• Plan, schedule, and perform regular supplier audits to ensure compliance with ISO 13485 and FDA requirements
• Manage the supplier corrective action system (SCAR) by reviewing requests and compiling metrics
• Track and analyze supplier performance using established metrics and recommend corrective actions
• Oversee the Approved Supplier List (ASL) and ensure proper evaluation and qualification of suppliers
• Maintain accurate documentation related to supplier qualifications, audits, and performance
• Support the Supplier Management process in the electronic Quality Management System

Requirements

• Bachelor’s Degree or equivalent combination of education and experience
• 5+ years of experience in supplier quality management, supplier audits, or quality assurance
• Experience within medical device or regulated manufacturing industries
• Knowledge of ISO 13485 and FDA QSR regulations
• Lead auditor certification through an accredited organization
• Ability to travel to supplier locations approximately 20% of the time, including internationally

Preferred Qualifications

• Proficiency with Netsuite or other ERP Software
• Experience with Grand Avenue Software
• CSQP or related certification
• Six Sigma belt certification