Lyvia Núñez Schmidt

Experience

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  Ocular Sciences

  Mar 1995 - Jan 2006

  Supervised the following departments: • Incoming – Raw material sampling, testing and approval• Chemistry Lab – Analytical methods for material and final products analysis. Suppliers Audits• Manufacturing Laboratories – In charge of monomer and packaging solution laboratories. Responsible for Laboratory investigations. Organizes and directs the daily activities of the laboratory. Responsible for supervising laboratory personnel, conducting and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting lab results. Responsible for laboratory investigations, training, procedures updates. Metrology equipment validation (IQ/OQ) - Develop validation protocol, validation executions and protocol closure. Process transfer between manufacturing plants. Organizes and directs the daily activities of the laboratory. Responsible for supervising laboratory personnel, conducting and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting lab results. Leader of the implementation laboratory setup, equipment installation and validation. Product validation Responsible of complete production plan by scheduling and assigning personnel of the injection molding area, accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results of the processing flow on shift production summaries. In charge of transfer laboratory from the UK to PR including: new procedures, equipment acquisition and installation. Also responsible for weekly planning schedule and monomer manufacturing.

  • QA Laboratory Manager – Incoming, chemistry lab and manufacturing laboratories, Supplier Audit

    Jan 2004 - Jan 2006

  • Manufacturing Laboratory Supervisor – Packaging and monomer manufacturing solutions

    Jan 2002 - Jan 2004

  • QA Laboratory Specialist- – Validation

    May 2001 - May 2002

  • Laboratory Specialist – Supervisor / Process Transfer

    Oct 1999 - May 2001

  • Manufacturing Supervisor

    Jul 1999 - Sept 1999

  • Laboratory Technician – Process transfer

    Mar 1995 - Jul 1999
• 

  CooperVision

  Jan 2006 - Jan 2007

  Manufacturing Laboratory Manager – New Product transfer leader from R & D

  Leader of the implementation of analytical methods, new mixing process, new procedures, laboratory setup and supplier management. Responsible for the implementation and construction of the new laboratories. Hiring the new personnel and training.

• 

  CooperVision

  Jan 2008 - May 2022

  Manufacturing Laboratories (Hydrogel / Silicone Monomer Formulations and Packaging Solution Laboratories)Responsible of the following activities:• Manufacturing Laboratories – Responsible for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and staff members in the laboratory. Develop laboratory budget. Responsible for laboratory investigations, and improvements. • Subject matter expert for the Manufacturing Laboratories and Materials of CooperVision Americas Manufacturing Operations. Show less Manufacturing Laboratories (Hydrogel & Silicone Monomer Formulations and Packaging Solution Laboratories)In charge of the following activities:• Manufacturing Laboratories – Responsible for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and staff members in the laboratory. Develop laboratory budget. Responsible for laboratory investigations and improvements.• In charge of transfer a new laboratory from the CooperVision Facilities Hungary/UK to Costa Rica and PR including: New procedures and translation, equipment acquisition, equipment installation, validation of equipment/mixing process, new mixing process for monomer and packaging solution, supplier management, employee recruitment and training laboratory technicians. Responsible for the development of the new procedures, risk assessments and the documentation related to the ECO's (engineering change orders). Show less In charge of the following activities:• Incoming – Raw material sampling, testing and approval• Chemistry Lab – Analytical methods for material and final products analysis• Manufacturing Laboratories – In charge of monomer and packaging solution laboratories for contact lenses.• Leader of the implementation of analytical methods, new mixing process, new procedures, laboratory setup and supplier management.• Responsible for laboratory investigations. Procedures development. Show less

  • Manufacturing Laboratory Senior Manager

    Jan 2019 - May 2022

  • Manufacturing Laboratory Manager / New Product transfer

    Jan 2013 - May 2022

  • Manufacturing Laboratory Manager Silicone products

    Jan 2008 - Jan 2013
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  Medtronic

  Oct 2019 - now

  Senior Manager

  Senior Quality Application Manager responsible for the Business Units of Heart Failure, Low Voltage, High Voltage and Final Pack. Responsible for the Quality Operations team.