Quality Systems & Compliance Engineer I
Core
Ensures compliance with FDA, ISO, and other regulatory requirements for the Quality Management System and administers the Learning Management System (LMS) for training.
Role type
Quality Systems & Compliance Engineer
Builds
Quality Management System elements and employee learning maps
Domain
Medical device manufacturing (Electrophysiology)
Deliverable
dashboards & analysis
Required skills
Quality Management Systems (QSRs, ISO 13485, ISO 9001), LMS administration, audit support, regulatory compliance documentation, MS Office proficiency
Preferred skills
Power BI, Six Sigma, ASQ CQE certification, medical device industry experience, supervisory experience
Responsibilities
Create and maintain employee learning maps, manage LMS audience structure, oversee training planning and execution, support internal and external audits, facilitate closure of audit nonconformances, provide input to management reviews on audit results
Seniority
Entry-level (0-2 years experience)