Global Post-Market Quality Specialist

Becton Dickinson; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD in San Diego, CA, seeks a Staff Specialist, Post Market Quality to lead post‑market quality activities across the MMS portfolio. You will work cross‑functionally with Quality, Regulatory Affairs, Engineering, and Operations to ensure timely, compliant management of recalls and surveillance.

The ideal candidate has 5+ years in medical device quality/regulatory roles, strong analytical skills, and the ability to influence stakeholders.

Qualifications

• Bachelor's degree in a technical field is required.
• Minimum 5 years in Quality, Regulatory Affairs, Post Market Quality, or related functions.
• Experience supporting post‑market quality activities, quality investigations, risk management, or field actions.
• Strong analytical, problem-solving, and decision‑making skills.
• Ability to influence cross‑functional stakeholders and drive alignment.
• Knowledge of global field action and post‑market surveillance requirements.

Responsibilities

• Lead and support the execution of global field actions (recalls, corrections, removals, advisory notices).
• Develop and maintain field action documentation, health hazard evaluations, and effectiveness strategies.
• Collaborate with regional teams to ensure consistent field action implementation across regions.
• Monitor progress, effectiveness, reconciliations, and closure activities for compliance.
• Support regulatory submissions and regulatory reporting including FDA 806.

Skills

Analytical thinking

Problem-solving

Decision making

Cross-functional influence

Data analytics & KPI development

Education

Bachelor's degree in Engineering/Quality/Life Sciences/Regulatory Affairs

Tools

CAPA processes

Job description

BD in San Diego, CA, seeks a Staff Specialist, Post Market Quality to lead post‑market quality activities across the MMS portfolio. You will work cross‑functionally with Quality, Regulatory Affairs, Engineering, and Operations to ensure timely, compliant management of recalls and surveillance.

The ideal candidate has 5+ years in medical device quality/regulatory roles, strong analytical skills, and the ability to influence stakeholders.