Senior Quality Engineer

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Senior Quality Engineer provides quality engineering leadership for manufacturing and post‐market activities supporting commercial medical devices. This role partners closely with Operations, Engineering, and Supply Chain to ensure regulatory compliance, effective risk management, and sustained product and process performance throughout the product lifecycle. Responsibilities focus on non‐design quality activities, including change management, nonconformance, CAPA, complaint investigations, and continuous improvement within a regulated environment.

Responsibilities:

• Provide quality engineering leadership and support for manufacturing, assembly, testing, packaging, and labeling operations, ensuring product quality and patient/user safety
• Ensure ongoing compliance with FDA QSR (21 CFR 820), ISO 13485, and applicable regulatory and quality system requirements
• Serve as the Quality representative on operations and sustaining teams, partnering cross‐functionally to balance compliance, risk, and business needs