Site CAPA Leader/ Quality Culture/ Systems
Core
Owner of the CAPA process and leader in promoting quality culture and continuous improvement within medical device manufacturing.
Role type
Senior Quality Systems & Continuous Improvement Lead
Builds
Optimized manufacturing processes and robust quality systems for medical devices
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA process management, manufacturing process knowledge, quality system expertise, continuous improvement methodologies, regulatory compliance analysis, audit leadership, process validation, GMP experience
Preferred skills
Six Sigma (Green/Black Belt), metrology and gauge fixture design, quality auditing certification
Technologies
GMP, Six Sigma, validation protocols
Responsibilities
Own the CAPA process, lead quality improvement projects, analyze and resolve quality issues, ensure regulatory compliance and training, assist in internal/external audits, validate process equipment
Seniority
Senior, hands-on IC
