Post-Market Quality Engineer I

Becton Dickinson NA; Covington (GA); On-site; USD 85,000 - 125,000; Full time

Job summary

BD in Covington, GA is seeking a Post-Market Surveillance professional to lead PMS activities for medical devices, ensuring reviews are completed on time and in compliance with ISO 13485, FDA QSR, EU MDR, and Health Canada requirements. You will partner with Quality, Regulatory Affairs, R&D, and Operations to maintain PMS plans and reports.

The role emphasizes data gathering from internal and external sources, analyzing safety information, documenting findings, and recommending improvements.

Qualifications

• B.S. in Engineering, Science, or mathematics field.

Responsibilities

• Lead PMS activities, ensuring reviews are completed on time and in compliance with regulations and standards.
• Develop and maintain Post-Market Surveillance Plans and Reports.
• Gather data from multiple internal and external sources.
• Analyze product performance and safety information.
• Document post-market findings with clear summaries, conclusions, and recommendations.
• Identify gaps and opportunities through PMS reviews and update product documentation as needed.
• Support improvements to PMS processes and related documentation.
• Collaborate with Quality, Regulatory Affairs, R&D, Clinical, Marketing and Operations to ensure timely PMS activities.

Skills

Post-Market Surveillance

Data analysis

Regulatory knowledge

Cross-functional collaboration

Education

B.S. in Engineering/Science/Math

Job description

BD in Covington, GA is seeking a Post-Market Surveillance professional to lead PMS activities for medical devices, ensuring reviews are completed on time and in compliance with ISO 13485, FDA QSR, EU MDR, and Health Canada requirements. You will partner with Quality, Regulatory Affairs, R&D, and Operations to maintain PMS plans and reports.

The role emphasizes data gathering from internal and external sources, analyzing safety information, documenting findings, and recommending improvements.