Specialist, Quality Assurance

Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country.

Cardinal Health Canada is currently seeking a Quality Assurance Specialist to join the Regulatory Affairs and Quality Assurance team. This role is a hybrid work-model with two days in our Mississauga Office.

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures.

The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities and reports to the Supervisor of Quality Management for Cardinal Health.

• Assists in the implementation and execution of the Cardinal Health Quality System for one or more Canadian distribution facilities, as necessary
• Participates in site quality audits, (internal and external) as necessary
• Assist with the development of procedures and work instructions for quality programs
• Executes on established quality policies and procedures Responsible for assisting in conducting quality-related training programs, as needed
• Executes on established quality policies and procedures
• Maintains quality-related metrics for assigned country and/or region
• Provides ongoing guidance to operations personnel regarding quality matters
• Experience with the FDA and Health Canada regulations is desirable
• Experience with local/Regional quality regulations, as necessary
• Executes on Inspections, Testing and Release activities in Canada for National Brand and Cardinal Brand Canada Suppliers, as necessary
• Execute on rework/relabeling activities as per protocols Coordinate NC/CAPA investigations and resolutions for events occurring at the sites
• Works with cross-functional teams (Operations, RA, Finance, Customer Care, Supply Chain, Transportation. Commercial, etc.) to optimize quality programs and manage issue resolution
• Maintains quality-related metrics for assigned sites
• Coordinate NC/CAPA investigations and resolutions for events occurring at the sites

• Bachelor’s degree in Science or Health Canada degree equivalency required
• 4+ years’ experience in related field, preferred.
• Comprehensive knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations, as an asset
• Highly organized, problem solving, analytical and focused
• Proven communication skills (verbal, written and presentation skills)

• Applies basic concepts, principles and technical capabilities to perform routine tasks
• Works on projects of limited scope and complexity
• Follows established procedures to resolve readily identifiable technical problems
• Works under direct supervision and receives detailed instructions
• Develops competence by performing structured work assignments

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not…