Post-Market Quality & Risk Engineer (Data-Driven)

REQ Solutions; Saint Paul (MN); Hybrid; USD 70,000 - 90,000; Full time

Job summary

REQ Solutions is seeking an engineer specializing in post-market surveillance and product performance analysis. The role focuses on investigating complaints, monitoring device performance, and collaborating across teams to ensure safety and compliance.

Candidates should have an engineering degree and experience with quality systems and statistical analysis. The position emphasizes teamwork, data-driven decision making, and process improvements in a medical device context.

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering.
• Understanding of quality system processes and procedures.
• Experience with statistical methods and data analysis.
• Desire to work in a team solving problems daily.

Responsibilities

• Investigate product complaints and monitor client product performance.
• Analyze post-market surveillance data for patterns and trends.
• Collaborate with cross-functional teams to mitigate risk and improve product performance.
• Provide input for process improvement and team strategies.
• Review completed product analyses to ensure field allegations are addressed.
• Assist in complaint investigations to ensure accurate and compliant documentation.
• Respond to Competent Authority requests as needed.
• Lead cross-functional project teams on select initiatives.

Skills

Technical writing

Quality systems

Statistical analysis

Cross-functional collaboration

Education

Electrical or Biomedical Engineering degree

Job description

REQ Solutions is seeking an engineer specializing in post-market surveillance and product performance analysis. The role focuses on investigating complaints, monitoring device performance, and collaborating across teams to ensure safety and compliance.

Candidates should have an engineering degree and experience with quality systems and statistical analysis. The position emphasizes teamwork, data-driven decision making, and process improvements in a medical device context.