Quality Engineer - Post-Market Surveillance & Data Insight

JobDiva, Inc.; Covington (GA); On-site; USD 60,000 - 85,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Quality Engineer I for Post-Market Surveillance to coordinate day-to-day PMS activities and write summary reports from diverse data sources. You will work closely with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations to deliver PMS reviews and related documentation.

The role emphasizes data analysis, report writing, and compliance with FDA/ISO/MDR and global standards within a mature quality system.

Qualifications

• B.S. in Engineering, Science, or mathematics field.
• 1-3 years of Quality experience in a medical device or pharma or other regulated industry.

Responsibilities

• Ensures post-market surveillance (PMS) activities are completed on time and in compliance with applicable laws, regulations, and company procedures.
• Responsible for post-market surveillance plans and reports including the compilation of data from various sources, analysis of the data, accurate representation of the product's post-market review, and summary of findings.
• Responsible for driving changes to product documentation to fill gaps discovered during the post-market surveillance review.
• Performs changes to the PMS process (including practice, procedure and associated documentation) as required.
• Coordinate and collaborate with Quality partners, R&D, Regulatory, Clinical Affairs, Marketing, and Operations to facilitate completion of the PMS Review process and builds productive multi-functional working relationships.
• Ability to discern when issues are to be raised to management for resolution.
• Ensures compliance to company procedures, external laws, and regulations when performing tasks.

Skills

Data analysis

Report writing

Cross-functional collaboration

Verbal and written communication

Microsoft Office

Multitasking and time management

Problem solving

Attention to detail

Regulatory knowledge basics

Education

B.S. in Engineering, Science, or mathematics

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Creative Solutions Services, LLC seeks a Quality Engineer I for Post-Market Surveillance to coordinate day-to-day PMS activities and write summary reports from diverse data sources. You will work closely with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations to deliver PMS reviews and related documentation.

The role emphasizes data analysis, report writing, and compliance with FDA/ISO/MDR and global standards within a mature quality system.