Quality Systems Specialist
Core
Support and strengthen the Quality Management System (QMS) to ensure compliance with internal policies and regulatory requirements for medical devices.
Role type
Quality Systems Specialist
Builds
Quality programs, systems, processes, and procedures for Medtronic Malaysia
Domain
Medical device manufacturing / Healthcare regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems and assurance principles, regulatory interpretation, audit and inspection management, CAPA documentation, process analysis, global standards alignment, continuous improvement, report writing
Preferred skills
Experience in regulated medical device or healthcare manufacturing environment, exposure to global or regional quality systems
Technologies
ISO 13485, MDSAP
Responsibilities
Oversee development and maintenance of quality programs and procedures; Provide expertise in interpreting regulatory and internal regulations; Conduct process analyses to enforce requirements; Lead audit and inspection preparation and resolution; Prepare reports and documentation including CAPA; Coordinate legal requests for government investigations; Facilitate uniform standards and best practice sharing globally
Seniority
Mid-level, independent contributor