QMS Specialist
Core
Ensure compliance with legal, regulatory, and international standards for the Quality Management System (QMS) through documentation, process improvement, and controlled execution of procedures.
Role type
Quality Management Systems (QMS) Specialist
Builds
Compliance with Philips Excellence Process Framework (PEPF) and Intra-Company Quality Agreements (ICQA)
Domain
Medical Device / Highly Regulated Industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS management, Quality Audits, Document Control, Audit planning, Training administration, Data Analysis, Regulatory knowledge
Preferred skills
eQMS (Trackwise, EtQ), ERP (SAP), ISO9001:2015, ISO13485:2016, Good Manufacturing Practices (GMP)
Responsibilities
Ensure site activities comply with PEPF and ICQA requirements; Manage local QMS processes and leverage compliance capabilities; Manage DHR review process and document control; Ensure proper audit planning and scheduling; Support training administration and contribute to training content; Collect and report metrics/KPI data to measure QMS effectiveness
Seniority
Mid-Senior, hands-on IC