Quality Engineer Validation Specialist

Risk-based validation expertise meets cGMP quality engineering at STEMCELL Technologies in Vancouver, supporting processes, methods, and equipment verification.

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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