PMS Quality Engineer: Post-Market Insights & Reports

TechDigital Group; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

TechDigital Group is seeking a Quality Engineer I to support Post-Market Surveillance (PMS) for medical devices. You will help ensure timely, compliant PMS activities and data-driven reports across Quality, R&D, Regulatory, Clinical Affairs, Marketing, and Operations.

Responsibilities include reviewing data sources, writing summaries, and driving updates to product documentation while aligning with ISO 13485:2016, FDA QSR, EU MDR, and related standards.

Qualifications

• Proficient in writing detailed summary reports and data analysis for conclusions.
• Excellent verbal, written, and presentation communication skills.
• MS Office proficiency including Word, Excel and PowerPoint.
• Able to manage multiple tasks concurrently and in cross-functional settings.
• Knowledge of product risk management and global regulatory standards.
• Basic statistics techniques and data interpretation.

Responsibilities

• Ensures PMS activities are completed on time and in compliance with laws and procedures.
• Compile PMS plans and reports from multiple data sources and summarize findings.
• Drive changes to product documentation based on PMS reviews.
• Update PMS processes, documentation, and related procedures as required.
• Coordinate with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations.
• Escalate issues to management as needed and ensure regulatory alignment.

Skills

Report writing

Data analysis

Communication skills

MS Office

Multitasking

Cross-functional collaboration

Risk management basics

Regulatory knowledge

Statistics basics

Education

BS in Engineering / Science / Mathematics

ASQ CQE / CQA certification

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

TechDigital Group is seeking a Quality Engineer I to support Post-Market Surveillance (PMS) for medical devices. You will help ensure timely, compliant PMS activities and data-driven reports across Quality, R&D, Regulatory, Clinical Affairs, Marketing, and Operations.

Responsibilities include reviewing data sources, writing summaries, and driving updates to product documentation while aligning with ISO 13485:2016, FDA QSR, EU MDR, and related standards.