Quality Engineer Validation Specialist
Job Description & How to Apply Below
As a Quality Engineer, you will support lifecycle verification across commissioning, qualification, validation, and project hand-over activities. You will collaborate with Manufacturing, Quality Control, Process Development, and Instrumentation teams. Your work includes risk assessments, protocols, schedules, master plans, and summary reports.
Key Responsibilities:
Develop metrics for process effectiveness and improvement progress
Support PPQ conformance lot manufacturing and increased testing
Perform non-conformance and CAPA investigations when needed
Prepare and coordinate validation, commissioning, and qualification documentation
Coach employees on applicable quality standards and procedures
Requirements:
Bachelor’s degree in Biomedical Engineering or equivalent
Two to six years of validation experience
Familiarity with risk management, ISO 14971, and cGMP
Experience qualifying utilities, facilities, equipment, and controlled temperature chambers
Strong technical report writing, analysis, project, and time management skills
Apply validation, risk management, and technical documentation expertise to quality assurance at STEMCELL Technologies in Vancouver.
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