Edith Perez-Criollo

• Responsible for all activities related to document and change control routing, distribution, and release to assure that the latest effective copies are available as required.
• Facilitated team meetings regarding implementation of new processes or updates related to QMS.
• Identified opportunities for process improvement within the organization's quality management system.
• Support in internal and external audits to assess compliance with ISO 13485 and FDA requirements.
• Ensured all personnel involved in QMS activities were properly trained according to organizational needs.
• Assisted in developing and maintaining document control procedures.
• Collaborated with multiple departments throughout an organization to ensure full integration of QMS into daily operations.

Training Coordinator Specialist

• Create curriculum, user groups, develop ILC training.
• Maintain, and report on the training program to support the Site.
• Supported onboarding of new employees by hosting orientation sessions.
• Identified and addressed training needs by collaborating with management and requesting more resources if necessary.
• Identified areas for improvement in training programs and collaborated with training team to implement changes.
• Maintained accurate records of all trainings conducted.
• Conducted needs assessments to identify gaps in employees' skills and knowledge.
• Assisted in designing, developing, and implementing new training methods and techniques.
• Coordinated with subject matter experts to develop effective training content.
• Updated existing curriculums based on changes in local procedures, new process or new standards.
• Developed targeted courses to achieve company training objectives and enhance skills of new employees in leadership roles.

Tool Control Coordinator

2015-2021

• Coordinate the Calibration and PM (preventive maintenance) for the entire site that include JRR Division and GQO.
• Liaison person between Stryker and TMI the calibration company.
• Train all Tools/Equipment owner on the Calibration process
• Open NC for all overdue equipment by department/tool owner

Production DHR Final Reviewer

2015-2021

• Coordinate the release of the final product before shipment.
• Review each DHR to confirm that the final product was built per the correct DMR prior shipment.
• Quarantine all product that were nonconformance.