CAPA Owner
Core
Lead CAPA investigations and execution for Interventional Guided Therapy systems (fixed interventional X-Ray systems) to ensure compliance with international standards and release new advancements.
Role type
Senior Quality Engineering Lead (CAPA)
Builds
Validated electrical (sub-) systems and solutions for Philips IGT Systems
Domain
Medical device manufacturing / Regulatory Quality Management
Deliverable
client delivery
Required skills
CAPA lifecycle management, root cause analysis, quality case management (QCM), ISO13485:2016, IEC60601-1, problem solving techniques, equipment and lab management, new product introduction, lifecycle development
Preferred skills
Mechanical/Electrical/Electronics/Mechatronics engineering background, experience in regulated industry, facilitation skills
Technologies
Quality Case Management (QCM) tool
Responsibilities
Execute CAPA from acceptance to closure, lead subject matter expert teams, create CAPA plans, ensure deliverables and timelines are met, maintain CAPA documentation in QCM, communicate progress to stakeholders, co-create team vision and strategy, maintain lab facilities and equipment quality
Seniority
Senior, hands-on IC with leadership responsibilities