Teams at IMRIS Inc.

Manage CAPA process and post-market activities including recalls, field actions, and health hazard evaluations. Lead investigations, root cause analysis, effectiveness verification, metrics, and continuous improvement within the QMS. Coordinate regulatory reporting, support audits/inspections, and partner with cross-functional teams to close quality system activities.

Support post-release medical device quality by leading design verification/validation, risk management (ISO 14971), design control, audits, CAPA/NCR management, regulatory compliance (FDA, MDSAP, ISO 13485, EU MDR), and cross-functional quality planning to ensure standards and readiness for inspections.

Lead manufacturing engineering for medical-device products: develop and improve production processes, tooling, work instructions, FMEAs and validations; support new product introduction; troubleshoot electromechanical systems; implement lean/KANBAN and continuous improvement; train and mentor production staff; collaborate with production, quality, design, and suppliers to ensure manufacturability, cost reduction, and regulatory-quality standards.