Perla Corvera

Introduction and validation of Electrical Test Equipment in the new Medical Facilities.

Creation of documentation for the introduction of the new Test Equipment: Equipment Manual, Preventive Maintenance Plan, MAintenance Work Instruction, First Article Inspection, Software Validation and Installation Qualification.

Improvement and updating of internal procedures and templates as the project require or as the client needed to improve the validations and to comply with all the FDA requirements.

Follow-up with different departments to keep changes or advances up to date.

Key team player by planning executions, acquire needed materials and training engineers and technicians in the validation process.

Managed a team of two interns to assist during the validation process.

Direct communication with the client from USA by email and phone.

Support to the manufacturing production line, in keeping the machinery setups and specs to keep a good yield and decrease the scrap and death times.

Validation Protocols execution

Modification to process and production documents.

Constant monitoring and support to manufacturing process.

Direct communications with clients from North Ireland by email.