Erica Green Email & Phone Number

United States

• Responsible for overall management of the Quality Management System (QMS) and ensures compliance to the latest version of ISO 9001 and ISO 13485.• Develops and delivers training programs to ensure employees are knowledgeable about quality standards and procedures.• Collaborates with cross-functional teams to establish and implement quality assurance processes.•Identifies and implements process enhancements to improve overall product quality and customer satisfaction.• Monitors and analyzes performance data to identify areas for improvement.• Conducts internal and external audits to verify compliance with quality standards and ISO requirements.

Tonawanda Ny

• Assists Quality Systems Manager in maintaining ISO 9001:2015 requirements and certifications.• Conducts internal audits, identifying process non-conformities and opportunities for improvement.• Maintains audit log and follows the responsiveness of the process owners on non-conformities treatment.• Monitors internal audits of the company according to the Audit plan and QMS procedure.• Conducts and prepares internal audit reports.• Manages supplier CAPA log and develops a working relationship with suppliers on their root cause. • Maintains employee training records and company safety records.• Assists in process improvement projects led by the Quality Systems Manager.• Assists department managers in creating and revising QMS documentation.• Facilitates New Hire Orientation to ensure awareness and understanding of the Quality Management System, ERP system, intranet, Safety and information security policy.• Manages calibration program, works with Internal departments and calibration service suppliers to arrange for timely handling of equipment requiring calibration.

Tonawanda Ny

• Ran and maintained supplier assurance program with precise attention to on time deliveries • Compiled and sustained material, parts inventory and status information to expedite movement of material to facility according to predetermined production schedules and order priorities• Schedule and confirm supplier appointments and onsite visits• Communicated with procurement team about project priorities and suppliers commitment dates to ensure on time delivers• Maintained Delivery and Quality metrics for outsourced suppliers• Managed supplier CAPA’s