María Laura Valverde Madriz

• Enhanced product quality by designing and executing rigorous testing protocols (IQs/OQs/PQs/PPQs) and developing the corresponding reports.
• Trained and mentored junior engineers, fostering a culture of continuous learning and professional development within the team.
• Developed technical documentation, including manufacturing process instructions, work instructions, preventive maintenance procedures, and engineering drawings to support manufacturing operations.
• Provided engineering support during new product launches, coordinating efforts between planning, production, and quality teams.
• Maintain constant communication with internal and external stakeholders regarding customer satisfaction and feedback on products and processes.

• Execute qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.

• Train manufacturing and quality assurance personnel in the assigned processes, validation protocols and the proper use of fixtures and any other required equipment.

• Attend and coordinate meetings to plan and share information related to Engineering, Quality, Regulatory and Project affairs.

• Update existing Device Master Records and Device History Records for the assigned manufacturing areas.
• Prepare and update work instructions and any applicable documentation required to sustain manufacture (Bill of Materials, Routings, Manufacturing Work Instructions, Labeling Specifications, etc.).