Facilities Engineer
Core
Implementing and maintaining the effectiveness of the Quality System and supporting site QA activities for regulatory compliance.
Role type
Quality System Engineer
Builds
Quality Management System processes and regulatory compliance documentation
Domain
Healthcare manufacturing (Cardiometabolic/Diagnostics)
Deliverable
dashboards & analysis
Required skills
Quality System implementation, CAPA management, document control, regulatory audit support, process improvement, supplier survey review, training program management, ISO/FDA compliance knowledge
Preferred skills
Electronic document control systems, QSR/ISO 13485/CMDR regulations, database management, quality management techniques
Technologies
MS Office (Excel, PowerPoint), electronic document control systems
Responsibilities
Implement and maintain Quality System effectiveness, participate in training and CAPA activities, maintain Quality metrics, support regulatory audits, manage training programs, review supplier surveys, assist with internal and agency audits, manage document control
Seniority
Mid-level IC