Full-Time Quality Specialist In Montreal

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 - Strong analytical mindset and organizational skills - Excellent communication in cross-functional settings
Bring your quality assurance expertise to help shape innovative medical solutions with Puzzle Medical Devices® Inc.#J-18808-Ljbffr