Quality Technician

3 weeks ago


Winnipeg MB, Canada Bioscience Association Manitoba Full time

Kane Biotech Inc. is a Canadian-based technology company engaged in the development and
Reporting to the VP Quality & Compliance, the Quality Assurance Specialist is directly responsible for the maintenance of Kane’s Medical Device Quality Management System and will serves as the designated Management representative responsible and accountable for quality system reporting. Position involves qualification and monitoring of Kane’s CMOs, contract testing laboratories, facilities, systems, equipment and processes in order to ensure compliance with applicable CGMPs and ISO 13485 certification. Host and participate in regulatory and certification processes and associated audits. This is an on-site position.

compliance and regulatory expectations are addressed. Prepares, conduct, and participate in in-house training initiatives.
• Prepares for and holds required Management Review meetings including assessment of Quality
Objectives and Policy.
• Supports Kane’s regulatory submissions, process and approvals.
• Vendor Management ensuring Kane selected vendors meet the required CGMP/ISO/regulatory
by/of vendors, regulatory agencies and certification bodies.
• or equivalent with a minimum of 5 years of related regulated industrial experience
• CGMPs, Validation, regulatory affairs, and auditing
• an executive level. Ability to read, analyze and interpret technical procedures, government regulations, guidance and
Excellent problems solving skills with the ability to define problems, collect data, establish relevant
Health and dental benefits
Short and Long-term disability plan
Shared contribution retirement plan
Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.


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