ELIZABETH GAROFALO

Quality Management representative for ISO 13485 certified organization.

• Developed and implemented quality assurance processes to ensure product compliance with customer requirements.
• Led the development and implementation of electronic quality management system in accordance with ISO 13485:2016 standards.
• Analyzed quality data and metrics to identify trends, drive improvements, and support decision-making processes.
• Established quality KPIs and reported on performance to senior management, highlighting achievements and areas for improvement.
• Managed the CAPA system while facilitating root cause analysis and implemented preventive measures to reduce defects and improve quality.
• Coordinated with cross-functional teams to ensure product compliance with quality standards and customer requirements.
• Managed internal audit program, identifying non-conformances and leading corrective action plans.
• Planned and delivered training sessions to improve employee effectiveness and address areas of weakness.
• Developed and maintained quality documentation, including quality manuals, policies, procedures, and records.

Quality Manager and Social Environmental Responsibility (SER) Manager, supporting ISO 9001:2015 products and operations.

• Managed alignment of the Quality Management System with ISO 9001 standards, regulatory requirements, and customer expectations.
• Recruited for Quality department, resolved performance issues, and fostered team productivity.
• Managed the monitoring, measurement, and review of internal processes.
• Report to top management on QMS performance metrics.
• Managed the CAPA process for the organization.
• Reviewed quality issues and non-conformances for root cause analysis, possible corrective action, and escalation.
• Developed, managed, and implemented the ISO 9001 quality system internal audit program.
• Responsible for identifying and training internal auditors, and for the final review of all audit reports.
• Managed the Responsible Business Alliance team to drive for successful readiness and certification.
• Implemented and supported corporate risk assessment activities across multiple functional areas, including EHS, QMS, Labor, Ethics, and Management Systems.
• Lead the implementation and transition of a paper-based Quality Management System to an electronic MasterControl system (EDMS).
• Leader and trainer in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) for the facility.
• Author/owner of QMS Standard Operating Procedures, and applicable quality documentation.

Quality Assurance Document Control Supervisor, supporting ISO 13485: 2016 Medical Device products.

• Responsible for the management of the document control process and all controlled documents for the organization.
• Provided daily guidance to direct reports related to the recommendations regarding the release, structure, and change of all controlled documentation.
• Managed the Document Control team, including setting daily priorities; provided feedback to management on individual performance; ensured Document Control personnel had been trained in required procedures.
• Responsible for quality validation performed for the document management system (including initial validation, updates, changes to processes, etc.).
• Final approval of all validation reports, SOPs, and all other quality system documents.
• Ensured the maintenance of a database of all filed documentation that ensures fast retrieval of documents.
• SharePoint site owner and developer, addressing all activities related to content and access permissions.
• Leader and trainer in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) for the facility
• Member of the Quality leadership team, contributing to systems development related to CAPA, complaint handling, non-conformances, validation, and ISO 13485 audit/certification readiness and development.

Quality/Regulatory representative for ISO 13485:2016 certified, FDA registered orthodontic lab, supporting a medical device.

• Provided daily supervision of the Quality Control department and ensures compliance with quality and regulatory requirements of the lab.
• Manages all activities related to product non-conformance, customer product/service complaints, and CAPA activities.
• Determines validation requirements and successfully executes protocols related to processes, equipment, and software.
• Develop and maintain pFMEAs, risk management files for processes.
• Responsible for raw material and final product inspection.
• Determine and manage equipment calibration requirements and activities.
• Conducts internal auditing and process improvement activities.
• Member of the leadership team, consistently providing innovative and cost-reduction initiatives.
• Updated and maintained the Quality Management System documentation to reflect current practices and regulatory changes.
• Identified opportunities for process improvements through data analysis techniques such as Six Sigma or Lean Manufacturing principles.
• Analyzed customer feedback data to identify areas for improvement in product design and development process.
• Determined training needs of staff and organized training sessions to achieve quality standards.

Quality associate responsible for the management of all controlled documents, supporting over 65 plasma donation centers across the United States.

• Develop standard operating procedures, as well as documentation management, administrator.
• Manage quality record retention and record storage activities for the organization.
• Certified corporate trainer / training system administrator.
• Quality compliance review of validation studies and protocols.
• CAPA team members are responsible for conducting investigations using root cause analysis.
• Certificate of Compliance Process Owner.
• Coordinate the training of new employees.
• Provide quarterly quality systems metric data.
• Quality check and proofread controlled regulatory documents; support internal and external quality system audits.
• Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) subject matter expert.