NOELIA POLANCO BAEZ

Oversee a clean room with a Responsibility of more 1,000 employees, with a volume of 6 MM sets of medical devices.

Manage and control product variances (material/labor/overhead), lead quality-focused projects to improve indicators

• Applies standard engineering techniques to design, analyze, test, maintain, repair or improve Products/ components.
• Analyzes, develops and evaluates systems.
• Designs and drafts blueprints with designer.
• Improves and maintains current systems or create brand new projects/ manage projects.

• Monitors projects and recommends changes to improve operating efficiency.
• Designs, develops, analyzes, troubleshoots, and provides technical skills during research and/or product development.
• Under the direction of the Engineer Section Head, provides technical direction to department engineers.
• Plans and coordinates larger scale/ Medium engineering projects.
• Design and execute validation protocols (PQ, IQ, OQ. TMV).
• Maintains a thorough knowledge of new developments and technology.

• Transfer of manufacturing lines.
• Design and execute validation protocols (PQ, IQ, OQ, TMV).
• Conduct Investigations as part of NCMR’s.
• Provide support in the drafting of APQ (Advanced product quality planning), EHS evaluations and corrective / preventive maintenance.
• Carry out / review manufacturing procedures, instructions and drawings ensuring compliance with international regulations (GMP, FDA, ISO).
• Participate and implement continuous improvement activities.

• Creation, maintenance, and updates of product structures (Bill of Materials).
• Updating and comparison of cost structures for changes in components and / or routes.
• Design and execute validation protocols (PQ, IQ, OQ, TMV).
• Plans and coordinates small engineering projects (example process changes in suppliers).
• Provide support to production operations (research, training).

• Support the accreditation and certification projects of the clinical laboratory and the blood bank in accordance with the CEDIMAT planning.
• Carry out the programming of training activities and implementation of the Quality Management System.
• Generate and publish the QMS indicators.
• Follow up on the approval of documents that support the QMS. Internal Procedures, Work Instructions, Job Descriptions, Process Flows, Process Map and the Forms and / or Records that support the QMS.
• Maintain control of changes, the issuance of documents and the availability of current information.
• Follow up on the Corrective and Preventive Action Program.