Post-Market Quality Engineer I

RXinsider LTD.; Covington (GA); On-site; USD 70,000 - 100,000; Full time

Job summary

BD in Covington, GA is seeking a Post-Market Surveillance professional to lead PMS activities, develop plans and reports, and drive timely, compliant reviews across regulatory requirements.

You will partner with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations to analyze data, document findings, and implement process improvements. A BS in engineering/science/math and 1–3 years PMS experience are preferred; ASQ CQE/CQA certifications are a plus.

Qualifications

• BS in Engineering, Science, or mathematics.
• 1–3 years experience in Post-Market Surveillance in the medical device industry.
• ASQ certification(s) (CQE, CQA, etc.) preferred.

Responsibilities

• Lead and manage Post-Market Surveillance (PMS) activities, ensuring all reviews are completed on time and in compliance with applicable regulations, quality standards, and company procedures.
• Develop and maintain Post-Market Surveillance Plans and Reports, including: Gathering data from multiple internal and external sources; Analyzing product performance and safety information; Accurately documenting post-market findings; Preparing clear summaries, conclusions, and recommendations.
• Identify gaps, trends, and opportunities through PMS reviews and drive updates to product documentation as needed.
• Support and implement improvements to PMS processes, procedures, practices, and related documentation.
• Partner closely with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations teams to ensure timely completion of PMS activities and reviews.
• Build strong cross-functional relationships and collaborate effectively with stakeholders across the organization.
• Escalate critical issues, risks, or compliance concerns to management when appropriate.
• Ensure all work is performed in accordance with company policies, quality system requirements, and applicable global regulations.

Skills

PMS experience

Data analysis

Report writing

Cross-functional collaboration

Risk management basics

Statistical techniques

Product risk management understanding

Education

BS in Engineering/Science/Math

Job description

BD in Covington, GA is seeking a Post-Market Surveillance professional to lead PMS activities, develop plans and reports, and drive timely, compliant reviews across regulatory requirements.

You will partner with Quality, Regulatory Affairs, R&D, Clinical Affairs, Marketing, and Operations to analyze data, document findings, and implement process improvements. A BS in engineering/science/math and 1–3 years PMS experience are preferred; ASQ CQE/CQA certifications are a plus.