Aylin - Quality Engineer Medical Devices Experience

Experiencia demostrada en Quality systems.

Experiencia demostrada en Quality Processes.

Experiencia demostrada en Laboratory testing.

Experiencia demostrada en Audit knowledge.

Experiencia demostrada en Tools.

Inspection and validation of raw material and packaging material according to specifications.. Verification of weights for capsules and powders to ensure compliance with quality standards.. Review and release/rejection of process lines, equipment cleaning and finished product.. Execution of action plans for NCR's, rework and deviations.. Implementation and monitoring of Good Documentation Practices (GDP).. Daily quality reporting and record management.. Performance of Laboratory tests such as moisture and hardness analysis using calibrated equipment.

Performed preventive maintenance of equipment in the clinical analysis laboratory of the hospital, following up on their records in logs and corrective maintenance reports with suppliers.. Supported the follow-up of the Biomedical Processes manual for the hospital's certification, as well as the application of Quality Management (FMS), keeping an inventory control of equipment and devices, as well as the elaboration of follow-ups for the control of the department.. Participated in surgical procedures such as laparoscopy, cystoscopy and colonoscopy in the handling of equipment and medical devices.

Responsible for the Robotics and Quality laboratory, supervising quality control technicians.. Execution of functional and inspection tests on robotic systems (Keyence, VPrep Velocity, etc) for finished products (pipettes).. Identification and segregation of non-conforming product.. Development of action plans, implementation of quality systems, product manufacturing guidelines and procedures (assembly, packaging and inspection), as well as management of files, records and daily quality and control reports.. Preparation of quality reports and communication of results to Quality manager.

Verification of correct operation of the medical equipment using simulators, tools and manuals.. Support in preventive and corrective maintenance activities.