Senior Quality Operations Engineer
Core
Ensuring high-quality performance, compliance, and oversight of Philips manufacturing processes for medical devices.
Role type
Senior Quality Operations Engineer (Medical Devices)
Builds
Manufacturing quality systems, validation protocols, and continuous improvement programs.
Domain
Medical Devices / Manufacturing / Quality Engineering
Required skills
FDA regulated environment experience, ISO 13485, CAPA management, PFMEA, root cause analysis, process validation, statistical analysis, environmental monitoring, sterilization validation
Preferred skills
ASQ-CQE certification, ISO Lead Auditor certification, cross-functional team leadership
Technologies
PFMEA, CAPA, ISO 14971, ISO 13485
Responsibilities
Support operations performance monitoring and reporting, handle nonconformance events and investigations, lead analysis of defects for disposition, facilitate Corrective and Preventive Actions (CAPA), manage process validation and New Product Introduction (NPI), deliver training programs on quality standards, manage incoming inspection and equipment control programs.
Seniority
Senior, hands-on IC