Elevate your career at Puzzle Medical Devices® Inc. as a Quality Specialist in Montreal. This full time, in-person role focuses on ensuring high standards in medical device manufacturing and validation. In this critical position, you will support the development and compliance of a percutaneous heart pump system. As a Quality Specialist, your responsibilities include managing supplier quality, guiding compliance with ISO 13485 standards, and participating in regulatory inspections. You will actively engage with cross-functional teams to maintain high-quality production standards. Key Responsibilities:
Qualify and manage suppliers per regulatory standards
Review supplier documentation and certifications
Support quality investigations and nonconformance resolutions




Execute software validation activities and maintain documentation
Collaborate with R&D;, manufacturing, and regulatory teams

Requirements:
Bachelor’s degree in Mechanical, Biomedical, or related field
Experience in a regulated medical device environment
Knowledge of ISO 13485 and FDA QMSR
Solid analytical mindset and organizational skills
Excellent communication in cross-functional settings

Bring your quality assurance expertise to help shape creative medical solutions with Puzzle Medical Devices® Inc. #J-18808-Ljbffr

📌 Full Time Quality Specialist In Montreal
🏢 Puzzle Medical Devices
📍 Montreal