Yaritza Perez Email and Phone Number

• Conduct meetings with team to collaborate on Validation documents and time frames.• Redact and execute protocols validations and reports including IQ, OQ and PQ for medical devices manufacturing equipment and processes.• Conduct meetings with machine manufacturer and service providers to achieve proper and optimal operation of the manufacturing equipment.• Audit and approve Validation Supporting documents using Ignite System.• Develop standard work procedures for a new manufacturing process.

• Submit Capital Request for VIP Projects• Coordinate equipment installation and Validation Activities• Manage Project Timelines• Develop new projects requirements• Maintain communication with new technology suppliers• Request Change Orders through Agile System• Evaluate facilities requirements for new equipment installation at Manufacturing Clean room• Implement and monitor project schedules.• Report project progress to Manager.• Assemble project closeout documents and presentations.• Lead management post project subcontractor review.

• Submit projects plans and implementation through Trackwise as the Change control Owner role.• Submit evidence of tasks completion through Trackwise system.• Develop and perform IQ/OQ/PQ software Validation protocols.• Review and validate all documentation impacted by the change including electrical drawings of medical devices manufacturing equipment.

• Develop and perform IQ/OQ/PQ software Validation protocols• Order parts for new manufacturing equipment development• Coordinate jobs with Automation Technician for projects development and validation• Develop medical devices product Failure and Mode Analysis documentation

• Perform process validation on process changes driven by new ideas or improvement.• Plan and perform continuous improvement projects for automated machines and packaging machines.• Perform environmental assessment to every new equipment or improvement projects.• Develop and Schedule manufacturing equipment preventive maintenance.• Supervise maintenance mechanics, technicians, technologist and a Lead Technician coordinating trainings and evaluating performance.• Schedule New Equipment projects from User Requirements through acceptance at manufacturing facilities and all validation required.• Support Medical Devices complaints investigation• Support internal OSHA and FDA audit activities and correct findings to comply with requirements.• Schedule New Equipment projects from User Requirements through acceptance at manufacturing facilities and all validation required.