Quality System & Compliance Expert
Core
Lead CAPA processes, quality engineering, validation, and audits for medical device manufacturing.
Role type
Senior IC quality system and compliance expert
Builds
compliant medical devices (peritoneal and hemodialysis components)
Domain
Medical devices / Dialysis manufacturing
Required skills
CAPA management, root cause analysis, validation planning, audit support, risk assessment, documentation control, process improvement
Preferred skills
knowledge of single-use sterilized devices, cross-functional collaboration
Technologies
SAP, SharePoint, NC/CAPA databases
Responsibilities
Manage NC/CAPA intake, investigation, and closure; deliver training on quality databases; prepare metrics for management; support validation and change control; act as reference during internal and regulatory audits; ensure compliant documentation.
Seniority
Mid-level, hands-on IC