Quality Engineer II
Core
Support, maintain, and continuously improve the Quality Management System (QMS) to ensure effective quality processes, accurate documentation, training compliance, and adherence to regulatory requirements.
Role type
Quality Engineer
Builds
Pharmaceutical quality documentation and training systems
Domain
Medical Devices / Pharmaceuticals
Deliverable
dashboards & analysis
Required skills
CAPA management, document control, change management, quality records management, training administration, regulatory compliance, process improvement
Preferred skills
MasterControl system proficiency, continuous improvement methodologies
Technologies
MasterControl
Responsibilities
Lead implementation of assurances, documentation control, training support, and CAPA systems; Maintain pharmaceutical quality documentation within MasterControl; Create, issue, revise, archive, and retrieve controlled documents; Support administration and maintenance of employee training requirements; Manage and support Quality events and CAPA process; Support investigation, documentation, and closure of quality issues; Review and implement global Quality System updates.
Seniority
Mid-level IC