Manuel J. Morales-Robles

Experience

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  Isla Viento

  Oct 2009 - Jan 2012

  Industrial Engineer

  Strategic Consulting, including viability studies, life cycle assessment, turbine selection, tower array and projects power production.Company liaison in Puerto Rico, identified key individuals related to the renewable energy space both in Puerto Rico and in the United States. Developed and actively participated in project presentations between the company's management team and environmental groups, local competitors in the renewable energy industry, banking officials, and local government agencies. Show less

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  Raul Rosa Distributors

  Jun 2010 - Aug 2010

  Consultant - Process Improvement

  Partnered with RRD’s management team to implement lean methodologies and developed strategic management plan from define phase through implementation; established new inventory monitoring methodology, standard operating procedures, and reorder points for their expansion plans.

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  E.C.O.S.S.S., Corp.

  Jan 2012 - Dec 2014

  Co-Founder

  Research & Development Company specializing in the design, development and prototyping of vertical farming technologies. Led and managed:• Business plan development • Production processes standardization• Production modules design• Market research analyses • Leveraging of international and national contacts to establish business networks • Purchasing for component parts• Strategic planning • Production layouts optimization and input/output operations improvements Show less

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  Teamship Development Group

  Sept 2012 - Sept 2013

  Administrative Manager & Junior Consultant

  • Organized and supervised daily activities for business support and development, including acquiring leadership development programs from the U.S. to be distributed across the Caribbean and Latin America. • Certified Leader in:o Multipliers (Leadership development program) – The Wiseman Group o “Inteligencia Emocional” – Teamship Development GroupClaro P.R.; Hato Rey, PR – Consultant (Under union strike environment)• Analyzed internal and external processes [one-on-one interviews, mystery shoppers, surveys, etc].• Delivered culture shaping workshops from small to large groups in challenging environments.Green Windows, Inc; Bayamón, PR – Consultant • Applied industrial engineering principles to define and lead the strategic implementation of continuous improvement projects in a job shop environment to deliver cost, quality and safety improvements to clients. • Led and participated in business development strategies. Show less

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  ASERE - Asesoria Responsable

  Sept 2013 - Oct 2015

  Technical Services Consultant

  • Provided support in the development and project scheduling of a Plant-wide Process Mapping Tool to monitor process flow, machine operations, along with all documentation related to manufacturing cells.• Worked on Internal Control project to audit previous equipment validations. • Analyzed and developed non-conformance reports, compliance risk analyses, and validation assessments to comply with FDA regulations, as well as to document areas of opportunities for continuous improvement. • Analyzed and developed requirement specifications for capital appropriation requests. • Executed from start-to-finish validation process to visual and computer aided inspection systems. • Created MS Project and MS Excel tracking tools to standardize the performance metrics review across validation projects. • Developed, trained, and implemented local procedures for inspection equipment. • Met and coordinated with contributors, approvers, and managers to effectively streamline validation documents among 15 SMEs, nine (9) area owners, contributors, validation specialists, and top managers who were stakeholders in the projects validation scope. • Use of Documentum systems and Gagetrak. Show less

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  X6Sigma

  Oct 2015 - May 2017

  Quality Engineer

  Manufacturing Engineering Consultant Medtronic; Juncos, PR – Diabetes, Sensor Division • Developed and implemented production methods and controls to meet quality standards in most cost efficient manner.• Develop and execute Test Method Validations for in process inspections and final inspections. • Investigate and resolved work-in-process problems. • Recommended and implemented improvements and modifications in sequence of operations, equipment utilization and related matters. • Monitored assigned operations to assure compliance with approved methods and standards. Quality Engineering Consultant Medtronic; Juncos, PR – Diabetes, Sensor Division • Work as a Quality Engineer for the Lean Conversion project implemented in the Sensors Manufacturing Area.• Evaluated current and potential risks within the Manufacturing process to standardize, align, and update the product defect codes into the pFMEA of the Enlite 1 glucose sensor.• Developed a report generating tool for daily and monthly monitoring of nonconformance’s, RTY, and investigation performance metrics for the Sensors Quality Engineering Team.• Analyzed and developed non-conformance reports, compliance risk analyses, and validation assessments to comply with FDA regulations, as well as to document areas of opportunities for continuous improvement. Show less

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  Ethicon, Inc.

  Jun 2017 - Jul 2018

  Supplier Quality Engineer

  • Developed a document tracking tool for CAPA project.• Evaluate Supplier related Non-Conformance events and enforce Critical to Quality requirements, as per Material Specifications. • Engaged cross-functional groups to reach collaboration to ensure supplier quality standards are in place. • Challenge and ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

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  Sterilmed, a Johnson & Johnson Company

  Jul 2018 - Jan 2021

  Staff Supplier Quality Engineer
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  Johnson & Johnson Vision

  Jan 2021 - now

  Staff Engineer External Manufacturer Supplier Quality