Director, Quality Assurance

General Accountability

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. 

Duties & Responsibilities

Quality Management System Leadership 

• 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. 

Design & Development Quality 

• 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. 

Design Transfer & Manufacturing Quality 

• 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. 

Post‑Market Quality 

• 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. 

Leadership & Strategic Contribution 

• 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. 

Key Attributes

• A minimum of a bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Systems, or related field). An advanced degree is a plus.
• 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. 

We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.

The expected base salary range for this role is $150,000 - $200,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.

We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.