Manuel Plazola

Experience

• 

  Becton Dickinson

  Jun 1987 - now

  QA Manager

  • Appointed as the Management Representative for the Nogales Plant (as defined per ISO 13485 and 21 CFR Part 820), Responsibilities include: 1) ensuring processes needed for the quality management system are established, implemented and maintained; 2) reporting to top management on performance of quality management system and any need for improvement through Management Review meetings; and 3) ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.• Primary contact for the Nogales site for FDA, ISO and other third-party inspections/audits of the quality system and/or the state of regulatory compliance for the Nogales plant.• Oversees the quality activities and compliance programs for the Plant including CAPA, Quality Notification’s, Temporary deviations, Internal / External Audits, Supplier Audits, Change Control, Calibration, Complaint Investigations, etc.• Participate in vendor certification/qualification activities.• Member of the Plant Leadership Team and Plant Executive Steering Committee (ESC) to support plant initiatives and goals.• Responsible for developing and maintaining the strategic quality plan and policies to define the overall quality practices, resources and activities to meet business and regulatory requirements for quality of products and services.• Responsible for the Quality department budget for the Plant.• Comply with all local, state, federal and BD safety regulations, policies and procedures.• Liaison with other countries as regulatory affairs for registration purposes• Comply with all local BD Quality policies, procedures and practices through consistent application of sound quality assurance principles. Show less

• 

  BD

  Jul 2006 - now

  Accountable for Quality Assurance Department, Incoming Inspection, Metrology and Microbiology Lab.Regulatory Affairs Person for Product Registration purposes

  • Sr QA Manager

    Jul 2006 - now

  • Sr QA Manager

    Jul 2006 - now
• 

  Becton Dickinson Nogales

  Jun 2017 - now

  Sr QA Manager