Quality Operations Manager
Core
Manage the Quality Operations team and execute activities for Philips' Image Guided Therapy Devices to ensure regulatory compliance and product quality.
Role type
Senior IC Quality Operations Manager
Builds
Medical device manufacturing processes and quality assurance deliverables
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulated medical device environment experience, Operations Quality (IQ/OQ/PQ), CAPA activities, internal/external audit programs, Medical Device regulations (ISO 13485/14971, 21CFR, MDD/EU MDR, cGMP, GDP), Quality KPIs/Data Analysis, Cross-functional team management, Budgeting, Workforce planning, Performance Management, Root cause analysis, Calibration management
Preferred skills
ASQ certifications, Functional team management experience
Technologies
ISO 13485, ISO 14971, 21CFR, EU MDR, cGMP, GDP
Responsibilities
Implement policy changes and ensure product quality, Manage/mentor the Quality Operations team, Drive quality investigations and corrective action plans, Support internal/external audit programs, Manage calibration activities and resource optimization, Monitor operational KPIs and lead continuous improvement efforts
Seniority
Senior, hands-on IC with team management