Quality Professional with proven experience in Medical Device Manufacturing Industry. Exposure in IVD (Invitro Diagnostic) and Medical device disposable (Is & IIa).
Quality Management System:
• Established & Maintenance of Quality Management System.
• Scheduling and chairing of Quality Management Review meetings.
• Execution of Internal Quality Audits, issuance of audit reports
• Raising of Corrective and Preventative Actions and coordinating and monitoring to ensure completion of the agreed activities by the relevant departments.
• Preparation and control of Quality Manual, Technical Construction File, CE marking doc, SOP & Forms. MDD Directive: 93/42/EEC
• Supervisory maintenance of all logs (e.g. raw material reports, in process reports, Labeling, batch release reports, NC reports, CAPA reports, Training record etc.)
• Control and day to day upkeep of Master Documents record, DCR record, issuance of Report Numbers, etc.
Validation & Calibration:
• Process and Product Validation and verification.
• Costing, scheduling and supervision of all validation activities for ISO 8 Clean room (Microbiological & HVAC validation), product stability and sterilization chamber (Ethylene Oxide sterilization).
• Issuance & maintenance of all validation & calibration record.
• Scheduling, acquisition of all calibration quotation and supervision activities of calibration.
• Managed & conduct internal and external EN ISO 9001 & 13485 audit program, including close out findings, creating audit findings reports and determine proper corrective actions.
• Assessment, Evaluation and approval of vendors, including issuance receipt and inspection of Quality Questionnaires, receiving inspection of goods.
• Execute supplier complaint report for any non conformance.
• Establish and maintain comprehensive system of Product Traceability.
HOURS OPERATION : 5 HOURS ON WEEKDAYS & 12 HOURS DURING WEEKEND
COMMUNICATION THROUGH EMAIL