Edwin Galisanao

Quality Assurance Manager at ONICON Incorporated / Air Monitor Corporation
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Contact Information
us****@****om
(386) 825-5501
Location
Santa Rosa, California, United States, US
Languages
  • Filipino -
  • Tagalog -
  • Visayan -

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Experience

    • United States
    • Appliances, Electrical, and Electronics Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Manager
      • Jan 2019 - Present

    • United States
    • Health, Wellness & Fitness
    • 1 - 100 Employee
    • Quality Assurance Manager & Regulatory Affairs
      • Sep 2013 - Dec 2017

      Responsible for the development, improvement and administration of the company's Quality System based on US / FDA's Title 21 CFR, Part 111 (cGMP for Dietary Supplements). Managing the company's Quality documentation system and other related systems. Developed and maintains the company's in-house Product Stability Studies program. Write procedures and ensure company personnel’s adherence to standards and continuous improvement of every quality system element in place. Oversee company-wide adherence to Regulatory Affairs requirements and provide necessary documents related to Regulatory Compliance and other documents requested by other departments within the organization as well as by customers. Represent the company’s Quality Department and interact with customer’s Quality Managers as well as interact with Quality personnel from Contract Manufacturers, and Supplier’s in the supply chain. Show less

  • Innovative Molding, Inc.
    • Rohnert Park, CA - USA
    • Quality Assurance Manager
      • Oct 2007 - Sep 2012

      Responsible for the development, improvement, implementation and administration of the company’s Quality System using ISO 9000, GMP and FDA-IMS guidelines. Responsible for the company’s Quality System’s Document Control. Develop Training Modules, write procedures and ensure company personnel’s adherence to standards and continuous improvement of every sub-system in place. Provide necessary documents related to Regulatory Compliance requirements and other documents requested by Customers. Represent the company’s Quality Department and interact with customer’s Quality Managers as well as Supplier’s or Vendor’s reps. (Major customers include Costco, Herbalife, Pharmavite, CytoSports and other companies engaged in the Nutritional, Pharmaceutical and Food packaging industry. Show less

    • Quality Assurance Manager
      • Oct 2000 - Sep 2007

      Responsible for the development, improvement, implementation and administration of the company’s Quality System based on ISO 9002 Quality System Standard. Write procedures and ensure adherence to standards and continuous improvement of the system. Coordinate with other department managers within the company engaged in mechanical engineering and contract manufacturing for the telecommunication and other electro-mechanical industry. Represent the company’s Quality Department and interact with vendor and customer’s Quality representatives. (Major customers include Advance Fibre Communication (AFC), Calix Networks, Inc., Gluon Inc., Symmetricom, LightGuard Inc. and PEK Preservation Systems). Show less

  • Icore-Entraco
    • Healdsburg, CA - USA
    • Quality Assurance Manager
      • Nov 1998 - Oct 2000

      Responsible for the administration and implementation of the Quality System for a company engaged in the design and manufacture of electrical conduit, harnesses, wiring assemblies, electrical interconnect and hardware for the Aerospace and Shipbuilding Industry. (Major customers include; Matsushita Avionics, Lockheed Martin Corp., Sikorsky Aircraft Co., British Aerospace, Bath Iron Works Corp., Ingalls Shipbuilding Co. and the U.S. Military). Coordinate with other department managers within the company. Represent the company’s Quality Department and interact with vendors and customer’s Quality Representatives. Show less

    • Manufacturing Manager
      • Aug 1997 - Oct 1998

      Managed manufacturing operations for a company engaged in the manufacture of RFID Tags, Antennas and Interface Controls. Supervised assembly and test Technicians. Scheduled production considering manpower, capacity, parts inventory, and shipping schedule. Coordinate with Engineering as well as QA and Materials Management Departments regarding specs, process, quality, productivity and availability of materials. Directed implementation of company policies and procedures, quality systems and process monitoring. Responsible for staffing, training, performance reviews as well as motivating employees within the department. Conducts weekly production meetings and attend ECO / Staff meetings. Responsible for the development and implementation of the company’s ESD Control system, Calibration System and other systems related to manufacturing and the elements of the ISO 9000 Standard. Show less

Education

  • San Jose State University
    Quality Design & Manufacturing
    1997 - 1999
  • Feati University
    Bachelor's degree, Mechanical Engineering

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