Director of Quality Assurance

About the job

As a member of our Senior Leadership team, you will be responsible for developing, implementing and managing TMI’s quality strategy to ensure products, services and processes meet regulatory standards and customer expectations. You will also act as TMI’s Management Representative for the Quality Management System to ensure the integrity of the QMS by verifying that the requirements are effectively established and maintained.

Responsibilities Include:

Quality Assurance

• Implement policies, systems, procedures, and practices to ensure that quality system requirements are established and followed
• Direct quality assurance activities towards process improvement, continuous quality improvement.
• Deliver reliable, high-quality product manufactured through the provision of training and certification programs and processes, and pro-active planning activities, support systems and procedures
• Act as TMI’s Management Representative for the Quality Management System.

Supplier Quality Management

• Develop and implement a comprehensive supplier quality strategy aligned with the overall business goals, ensuring regular compliance and risk mitigation across the supply chain
• Lead supplier audits ensuring suppliers meet internal standards and industry regulations
• Establish and maintain KPIs to monitor supplier quality and drive continuous initiatives
• Verify that the Company suppliers and subcontractors have required quality assurance procedures and processes in place that meet and support company requirements.

Auditing

• Lead adequate internal auditing function to verify that the operations of all functional groups are in compliance with established standards
• Oversee external auditing of the vendor qualification function
• Represent the Company as the primary liaison for all third-party audits by customers and regulatory agencies.

Product Development Support

• Collaborate with Research and Innovation, Product Development and other cross-functional teams to support the delivery of improvements to existing and next generation products and services
• Promote inter and intra departmental procedures to facilitate effective communication and efficiency.

People Management and Departmental Administration

• Lead the quality team and function to inspire and drive performance across the entire quality system.
• Optimize the mix of internal controls and quality testing and supplier quality initiatives
• Drive system level thinking and controls across the organization and partner with manufacturing, engineering, and others to optimize our production system.
• Cultivate supplier relations & supplier quality systems that build trust and performance with efficiency
• Lead our people with integrity while demonstrating the TMI values
• Prepare departmental recommendations for annual budget submissions and work within approved departmental budget.

Health and Safety

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

Policy Compliance

• Adhere to all relevant policies, procedures, and legislation, including the Quality Management System.

QUALIFICATIONS

• Diploma or Degree in Health, Engineering, Biomedical Sciences or a related field of study
• 10 years of experience in preferably in a highly disciplined, regulated environment such as medical devices, pharmaceuticals, aerospace or automotive industries
• 5 years previous management experience
• Experience managing a Quality Management System (QMS)
• Expertise of Quality Management System standards, such as ISO13485 or ISO9001.
• Experience determining whether product meets requirements.
• Experience with and current knowledge of Canadian, European and U.S. quality assurance standards
• Experience in conducting review audits.
• Experience with cGMP, GLP and GCP is an asset
• Knowledge of statistical and reporting techniques
• Strong leadership skills
• Strong communication skills
• Strong consulting skills
• Strong interpersonal skills.

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.

Apply Via LinkedIn