Lead QMS and eQMS excellence onsite at Vital Bio, applying medical device quality expertise across regulated product development. As Senior QMS Quality Engineer, you will maintain, improve, and assess system effectiveness. You will partner with Quality, Regulatory Affairs, R&D;, Manufacturing, Operations, Supply Chain, and Program Management. Your work supports compliance, product development, verification, validation, commercialization, and post-market activities.

Key Responsibilities
- Maintain and improve QMS compliance with regulatory requirements
- Administer eQMS workflows, reports, dashboards, and metrics
- Lead CAPA, nonconformance, deviation, and change control
- Plan and support audits, inspections, and corrective actions
- Support design controls, risk management, and commercialization

Requirements:
- Bachelor's degree in a related technical discipline
- Seven years of regulated medical device quality experience
- Five years supporting ISO 13485 and FDA-compliant QMS
- Experience administering electronic quality management systems
- Knowledge of ISO 14971, MDSAP, and FDA QMSR Bring QMS leadership, eQMS administration, CAPA expertise, and audit readiness to Vital Bio’s diagnostic products.

📌 Senior QMS Quality Engineer (Oakville)
🏢 Vital Bio
📍 Oakville