Quality Engineer I — Post-Market Focus

Regulatory Jobs; Covington (GA); On-site; USD 75,000 - 105,000; Full time

Job summary

BD, a global medical technology leader, seeks a Post-Market Surveillance professional in Covington, GA to lead PMS activities, develop plans and reports, and ensure compliance with ISO 13485, FDA QSR, and EU MDR. You will collaborate with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations to close reviews on time and drive improvements.

Required: BS in Engineering/Science/Math and 1–3 years in PMS; ASQ CQE/CQA a plus.

Qualifications

• B.S. in Engineering, Science, or mathematics field.
• 1-3 years experience in Post-Market Surveillance in the medical device industry.
• ASQ certification(s) (CQE, CQA, etc.) preferred.
• Proficiency in writing detailed summary reports and analyzing data to draw conclusions.
• Strong listening, questioning, problem solving, conceptual thinking, and analytic skills.
• Ability to manage multiple assignments and work in cross-functional teams.

Responsibilities

• Lead and manage PMS activities, ensuring reviews are completed on time and in compliance with regulations and quality standards.
• Develop and maintain Post-Market Surveillance Plans and Reports, including data gathering, analysis, documentation, and summaries.
• Identify gaps, trends, and opportunities through PMS reviews and drive updates to product documentation.
• Support and implement improvements to PMS processes, procedures, and related documentation.
• Collaborate with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations to ensure timely PMS activities.

Skills

PMS knowledge

Data analysis

Report writing

Cross-functional teamwork

Regulatory knowledge

Statistical skills

Communication

Education

BS in Engineering/Science/Math

Job description

BD, a global medical technology leader, seeks a Post-Market Surveillance professional in Covington, GA to lead PMS activities, develop plans and reports, and ensure compliance with ISO 13485, FDA QSR, and EU MDR. You will collaborate with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations to close reviews on time and drive improvements.

Required: BS in Engineering/Science/Math and 1–3 years in PMS; ASQ CQE/CQA a plus.