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Director, Quality Assurance

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Profound Medical

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Location:
Canada , Mississauga

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

150000.00 - 200000.00 CAD / Year
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Job Description:

This role leads the Quality Assurance function for a medical device company specializing in incision-free therapeutic HITU robotic systems integrated with commercial interventional MRI platforms. The Director is responsible for ensuring full compliance with ISO QMSR, 13485, MDR, and MDSAP, driving quality excellence across R&D, design transfer, manufacturing, and post‑market quality operations. The position requires strong engineering expertise, risk‑based decision‑making, and the ability to collaborate effectively with cross‑functional teams. Lead the company in the development, implementation, maintenance, continuous improvement, and effectiveness of its Quality Management System (QMS). Direct supervision over the QA Team.

Job Responsibility:

  • Lead the development, implementation, maintenance, and continuous improvement of the regulatory compliant QMS
  • Serve as the Management Representative, reporting to senior management on QMS performance and improvement opportunities
  • Ensure effective document control, training, internal audits, CAPA, nonconformance management, supplier quality, and change control processes
  • Partner closely with R&D to ensure design controls are rigorously applied throughout the product lifecycle
  • Lead risk management activities (ISO 14971, DFMEA, PFMEA) and ensure risk files remain current and comprehensive
  • Ensure verification, validation, and usability engineering activities meet quality and safety requirements
  • Lead design transfer from R&D to manufacturing, ensuring readiness of processes, documentation, and controls
  • Conduct manufacturability assessments and collaborate with engineering to optimize product design for production efficiency and reliability
  • Oversee process validation (IQ/OQ/PQ) for manufacturing processes, test methods, and equipment
  • Ensure effective deployment and maintenance of the Device Master Record (DMR) and Device History Record (DHR)
  • Establish and monitor Quality Control processes, including incoming inspection, in‑process controls, and final release inspections
  • Manage complaint handling, failure investigations, root cause analysis, and corrective/preventive actions
  • Lead trend analysis and quality metrics reporting to drive continuous improvement
  • Ensure field actions, product improvements, and service processes are executed in compliance with regulatory requirements
  • Provide effective leadership to the QA team: set goals, develop talent, and ensure high performance
  • Establish and manage the QA department budget
  • Collaborate with cross‑functional leaders to align quality strategy with business objectives
  • Support the executive team with quality insights and operational decision‑making

Requirements:

  • A minimum of a bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Systems, or related field)
  • Quality Assurance certification (ASQ CQE, CQA, CMQ/OE) is an asset
  • 10+ years of experience in Quality Assurance within the medical device industry
  • 5+ years of leadership experience in a regulated manufacturing environment
  • Deep expertise in ISO 13485, ISO 14971, and medical device quality system practices
  • Strong engineering background with hands-on experience in: Design transfer
  • Process validation
  • Manufacturing quality controls
  • DMR/DHR management
  • Root cause analysis and problem-solving methodologies
  • Excellent communication skills and ability to influence at all organizational levels
  • Highly organized, dependable, and results-oriented
  • Proficiency with MS Office tools
  • Motivated to stay current with evolving quality standards and best practices
What we offer:
  • group RRSP
  • medical benefits paid by the employer

Additional Information:

Job Posted:
March 13, 2026

Employment Type:
Fulltime
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