Quality Engineer I: Post-Market Analytics & Patient Safety

TALENT Software Services; Arden Hills (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

TALENT Software Services is seeking a Quality Engineer to investigate product complaints and monitor post-market product performance for a client in Minnesota. The role emphasizes data-driven analysis, cross-functional collaboration, and adherence to quality systems to ensure patient safety and product reliability.

The successful candidate will review lab analyses, conduct investigations, and communicate findings to management and design teams, while contributing to process improvements and risk

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering.
• BS with 1-3 years of relevant experience.
• Strong desire to collaborate to solve problems.
• Understanding of technical engineering topics and applied statistics.
• Ability to independently manage projects and meet delivery dates.
• Experience operating within quality system processes and procedures.
• Strong written and verbal communication and data analysis skills.

Responsibilities

• Review completed returned product lab analysis, customer feedback and historical data to identify proper coding for product complaints.
• Perform complaint investigations in accordance with local and global processes.
• Analyze post market surveillance data for patterns and trends; support data bounding for document releases.
• Respond to Competent Authority Requests.
• Communicate post-market product information to management and design teams as needed.
• Provide input for process improvement and help develop tactical approaches to implement team strategies.
• Perform data analysis for Product Performance and Risk Management documentation using statistical methods and software.
• Lead cross-functional project teams as required; adapt to changing responsibilities as the department grows.
• Foster a diverse and inclusive workplace and address product line evolutions.
• Investigate and review electronic circuits and components; analyze returned products to address complaints.
• Assist Lab Technicians during investigations to ensure accurate and compliant product analysis and documentation.
• Review completed product analysis to ensure field allegations are adequately addressed.

Skills

Statistical analysis

Data analysis

Project management

Quality systems knowledge

Communication skills

Education

Bachelor's degree in Electrical or Biomedical Engineering

Job description

TALENT Software Services is seeking a Quality Engineer to investigate product complaints and monitor post-market product performance for a client in Minnesota. The role emphasizes data-driven analysis, cross-functional collaboration, and adherence to quality systems to ensure patient safety and product reliability.

The successful candidate will review lab analyses, conduct investigations, and communicate findings to management and design teams, while contributing to process improvements and risk