Design Quality Assurance Manager

POSITION SUMMARY The Design Quality Assurance Manager provides quality leadership and oversight for medical device design and development activities to ensure compliance with applicable regulatory and quality system requirements. This role partners closely with R&D and cross‑functional teams to embed quality, risk management, and patient safety throughout the product lifecycle. This role will require 30% travel. PRIMARY OBJECTIVES AND RESPONSIBILITIES Lead quality oversight for new product development, ensuring compliance with 21 CFR 820.30, ISO 13485, MDSAP, and applicable global regulations. Partner with R&D to ensure effective execution of design controls, including design planning, inputs, reviews, verification, validation, transfer, and maintenance of Design History Files (DHF).…