Juan Rosa

Juan Rosa

Quality Engineer

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location of Juan RosaDandridge, Tennessee, United States

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  • Timeline

  • About me

    Quality Manager at GE Healthcare- Retired

  • Education

    • East Tennessee State University

      1989 - 1992
      Master of Science Engineering Technology
    • University of Puerto Rico-Mayaguez

      1977 - 1982
      Bachelor of Science Agricultural Mechanization &Technology
  • Experience

    • Raytheon

      Jan 1987 - Jan 1993
      Quality Engineer

      •Quality Assurance support for the Patriot and SM2 programs.•Evaluated in-line items and disposition of non-conforming hardware.•Provided technical and floor support for circuit cards, cables and electromechanical assemblies.•Reviewed and approved work instructions and generated inspection criteria for the product.•Performed Surveillance Audits at suppliers.

    • Bristol Metals Incorporated

      Jan 1993 - Jan 1994
      Quality Assurance Manager

      •Developed Procedures and wrote manual for Quality Assurance.•Responsible for supervision and training of fourteen inspectors.•Directed and supervised welding improvement program.•Directed laboratory responsible for X-ray and mechanical testing of 300 series stainless steel pipe.

    • Amana - Raytheon

      Jan 1994 - Jan 1997
      Quality Engineer

      •Provided floor support to the manufacturing operation.•Conducted Process Capability Studies in assembly and fabrication processes.•Member of Warranty Task Force worked on projects to reduce cost.•Conducted internal audits of the Quality System for compliance to ISO 9001.•Provided feedback to design engineering for timely resolution of manufacturing issues.•Interfaced with suppliers and customers to resolve quality issues.

    • GE Healthcare

      Jan 1997 - now

      •QA Manager reporting to the Director QA / RA for Magnetic Resonance products.•Developed and implemented strategies to assure compliance with 21 CFR part 820 (FDA), ISO 9001, ISO 13485, EN 46001,Pressure Equipment Directive 97/23/EC and IEC 60601-1.•Responsibility included leadership and guidance for 3 QA Engineers, 1 QA Trainer and 3 QA Technicians.•Site representative during FDA inspections.•Monitored defect analysis and implementation of Corrective and Preventive Actions to drive process improvements. •Participate in weekly reviews to address Customer Complaints and drive resolution to the issues.•Member of New Product Introduction teams responsible for defining Regulatory Requirements for the products, interfacing with regulatory bodies and completing components risk assessment.•Responsible for maintaining UL file for all the products developed at the Florence plant.•Member of New Products Introduction teams. Responsible for approving Design Verification, Validation and Transfer plans. Review and approve test procedures.•Received the “expertise award” given by the GE Healthcare chief quality officer in 2007.•GE Hispanic Forum “Wall of Fame” recipient award in 2007.•Selected as member of global teams to prepare and assess sites for FDA readiness: China, India, Japan and United States. Show less

      • Quality Manager

        Jan 2001 - now
      • Six Sigma Black Belt-Quality

        Jan 2000 - Jan 2001
      • Quality Engineer

        Jan 1997 - Jan 2000
  • Licenses & Certifications

    • ASQ Auditor

    • ASQ Biomedical Auditor

    • ASQ Quality Engineer

    • ASQ Quality Manager