Staff Specialist, Post Market Quality Job at Becton Dickinson, San Diego, CA

  • Becton Dickinson
  • San Diego, CA

Job Description

BD seeks a Staff Specialist in Post Market Quality to serve as a global subject matter expert for the Medication Management Solutions portfolio. The role involves leading field actions, risk assessments, regulatory compliance, and analytics while collaborating across Quality, Regulatory Affairs, Engineering, and regional teams.

Responsibilities

  • Lead execution of global field actions including recalls, corrections, removals, and advisory notices
  • Develop quality decisions through risk assessment and provide technical expertise on safety and compliance issues
  • Support FDA 806 reporting and regulatory submissions; prepare documentation for audits and inspections
  • Develop KPIs, dashboards, and reports analyzing field action effectiveness and quality trends
  • Drive process improvements and collaborate across Quality, Regulatory, Engineering, and Operations teams

Requirements

  • Bachelor's degree in Engineering, Quality, Life Sciences, or Regulatory Affairs
  • Minimum 5 years experience in Quality, Regulatory Affairs, or Post Market Quality in regulated industry
  • Experience with post-market quality activities, investigations, risk management, and field actions
  • Strong analytical and problem-solving skills with cross-functional influence ability
  • Medical device industry experience preferred
  • Knowledge of global field action requirements and complaint handling processes preferred
  • Experience with regulatory inspections and audit readiness activities preferred

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