Quality Specialist

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MONTREAL
, Quality Specialist, full-time, in-person

Puzzle Medical Devices® Inc. is developing a percutaneous heart pump for patients with advanced heart failure. The device’s design allows for safe percutaneous implantation to support both renal and cardiac function through a 4 mm-pump implanted in the descending aorta with a 4 Fr axillary driveline, allowing full patient mobility. To date, Puzzle Medical Devices® Inc. has successfully:

• Completed 3 financing rounds in 2022, 2023, and 2025;
• Completed its first-in-human study with all patients experiencing improvements in cardiac and kidney function from 2022 - 2024;
• Grew its team to ~50 people;
• Received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in 2021.

Position Summary

Puzzle Medical Devices® Inc. is currently seeking a Quality Specialist to support the development, manufacturing, and validation of our percutaneous heart pump system. This role is critical to ensuring that products, processes, and suppliers meet internal quality standards and applicable regulatory requirements.

Role And Responsibilities

• Qualify, monitor, and manage suppliers in compliance with internal quality standards and regulatory requirements
• Review and approve supplier documentation, certifications, and change notifications
• Support supplier audits, nonconformances, CAPAs, and quality investigations
• Review and approve job travelers, work instructions, manufacturing forms and records to ensure accuracy, control, traceability and QMS compliance
• Support document control and change management activities

Software Validation & Quality Systems

• Plan, execute, and document software and system validation activities (e.g., manufacturing software, test equipment, quality systems)
• Ensure validation activities comply with ISO 13485 and internal procedures
• Maintain validation documentation, traceability, and revalidation assessments
• Support internal audits, regulatory inspections, and quality reviews

Risk Management & Continuous Improvement

• Participate in risk management activities, including FMEA and process risk assessments
• Contribute to continuous improvement initiatives across quality, design and manufacturing processes

Cross-Functional Collaboration

• Work closely with R&D, manufacturing, operations, procurement, and regulatory teams
• Provide quality guidance throughout the product development and manufacturing lifecycle

Qualifications

• Bachelor’s degree (Mechanical, Biomedical, Industrial, or related field)
• Experience in a regulated environment (medical devices strongly preferred)
• Knowledge of quality standards and regulations such as ISO 13485, FDA QMSR, and GxP principles
• Experience with supplier quality, production documentation, and change control
• Familiarity with software validation principles and documentation
• Strong attention to detail, organizational skills, and analytical mindset
• Ability to communicate clearly and work effectively in a cross-functional, fast-paced environment

Bonus

• Experience supporting manufacturing of implantable or Class II/III medical devices
• Experience with audits (internal, supplier, or regulatory)
• Familiarity with electronic QMS tools
• Note:
  
  This job description is intended to provide a general overview of the position. It is not an exhaustive list of responsibilities, qualifications, or requirements. The employer reserves the right to modify the duties or requirements of the position as needed.