Quality Assurance Compliance Specialist
CurrentProject Medical Device Manufacturing Company• Developed and implemented a robust Risk Management process, following ISO 14971, resulting in a 25% reduction in product-related risks.• Conducted comprehensive risk assessments for new product designs, identifying and mitigating potential hazards and vulnerabilities, leading to a 30% decrease in adverse events.• Quality Management System (QMS) Improvement: Led the implementation of an enhanced QMS, aligned with ISO 13485 requirements, resulting in a 20% improvement in overall process efficiency.• Established key performance indicators (KPIs) to monitor quality metrics, resulting in a 15% reduction in non-conformities and a 10% increase in product reliability.• Implemented a supplier qualification and monitoring program, evaluating suppliers based on quality performance, resulting in a 20% reduction in supplier-related quality issues.• Implemented statistical process control (SPC) techniques, resulting in a 25% reduction in process variations and improved product consistency.• Corrective and Preventive Actions (CAPA): Led cross-functional teams to investigate and resolve non-conformances and customer complaints using root cause analysis (RCA) methodologies, resulting in an 80% reduction in recurring issues.• Compliance Audits and Regulatory Compliance: Conducted regular internal audits to assess compliance with regulatory standards and identified areas for improvement, achieving a 95% compliance rating.