Job opportunity
Full-Time Quality Specialist in Montreal
Puzzle Medical Devices® Inc.
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.
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Apply on source site 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