Processed and validated stakeholder data for system uploads, ensuring accuracy and compliance. Developed training materials and procedures for global teams. Executed data loads, troubleshot errors, and improved reporting efficiency. Delivered training sessions to suppliers, ensuring compliance and QMS requirements.

Created and maintained controlled documents, SOPs, and technical manuals for medical devices. Collaborated with engineering and quality teams to ensure documentation met regulatory standards. Supported audits by preparing document packages and ensuring inspection readiness. Developed training materials and job aids to support onboarding and compliance initiatives.

Supervised Documentation Center ensuring compliance with ISO 13485, FDA 21 CFR 820, MDSAP, BSI. Led Change Control Board activities, ensuring traceability and timely closure of documentation changes. Investigated Non-Conformances (NC) and managed CAPAs. Coordinated internal/external audits and served as Audit Scribe. Monitored departmental metrics and indicators, identifying trends and improvement opportunities. Designed and delivered training courses and materials for employees on SOPs, compliance practices, and system usage.

Supported ERP and MES validation testing (IQ/OQ/PQ), ensuring compliance with 21 CFR Part 11. Utilized MES platforms and MasterControl to monitor production documentation and ensure traceability. Created, reviewed, and updated SOPs and controlled documents. Investigated NCs and CAPAs, prepared metrics for change control, and supported product transfers. Developed training materials and courses for staff on document control systems, compliance requirements, and audit readiness.

Managed controlled documents, SOPs, and training records. Supported audits and ensured compliance with ISO and FDA standards. Collaborated with cross-functional teams to maintain inspection readiness.