Compliance and Quality Specialist (CAPA)
Core
Lead analysis of defects and non-conformances, manage dispositions, and facilitate Corrective and Preventive Actions (CAPA) to ensure regulatory compliance and patient safety.
Role type
Senior Individual Contributor Compliance and Quality Specialist (CAPA)
Builds
Quality Management System (QMS) improvements and operational excellence initiatives
Domain
Medical devices and/or pharmaceuticals (also automotive)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
defect analysis, non-conformance management, CAPA facilitation, process improvement, regulatory compliance, stakeholder management, independent work, pressure management, Microsoft Office proficiency
Preferred skills
medical devices/pharmaceuticals experience, automotive industry experience, ISO 13485/9001/14971 knowledge, FDA experience
Technologies
Microsoft Excel, Microsoft PowerPoint
Responsibilities
Lead group analysis of defects to determine dispositions of non-conformances, manage non-conformances, facilitate effective CAPA, propose and implement enhancements to processes and systems, drive overall quality performance and operational excellence
Seniority
Senior, hands-on IC
