Quality Engineer - Post Market Surveillance

Advantage Technical; Minneapolis (MN); On-site; USD 50,000 - 66,000; Full time

Job summary

Advantage Technical is seeking a Quality Engineer I to support post-market surveillance, monitor complaints, perform statistical analysis, and develop dashboards that enhance product quality and regulatory compliance.

The role collaborates with Quality, Regulatory, Clinical, Engineering, and Risk Management teams to drive data-driven decisions and continuous improvement, with opportunities to apply predictive analytics.

Qualifications

• Bachelor's degree in Statistics, Mathematics, CS, Data Science, Analytics, or related field.
• 0–3 years of data analytics or quality engineering experience.
• Power BI familiarity and data analysis skills preferred.

Responsibilities

• Monitor complaints, perform statistical trending, and identify quality concerns.
• Assess signals and communicate findings to management and stakeholders.
• Develop, maintain, and enhance complaint monitoring tools aligned with risk management documentation.
• Perform ad hoc data analyses for Quality, Regulatory, Clinical, Engineering, and other partners.
• Design, maintain, and validate Power BI dashboards, reports, visualizations, and analytical tools.
• Apply SPC techniques to evaluate product performance and identify meaningful trends.

Skills

Power BI

Data analysis

Statistics

Dashboard development

SPC

Cross-functional collaboration

Education

Bachelor's degree in Statistics, Mathematics, Computer Science, Data Science, Analytics, or related field

Tools

Power BI

Job description

Duration: 09/14/2026 - 09/13/2027

Pay Rate: $42.00/hr

Work Authorization Requirement: Applicants must be authorized to work in the United States without current or future visa sponsorship. Sponsorship is not available for this position.

Position Summary

The Quality Engineer I will support post-market surveillance activities through complaint monitoring, statistical analysis, and signal detection efforts designed to enhance product quality, patient safety, and regulatory compliance. This role is responsible for identifying emerging product performance trends, conducting risk-based analyses, and providing actionable insights to cross-functional teams across the product lifecycle.

The ideal candidate will have a strong analytical foundation with experience in data analysis, statistical methodologies, dashboard development, and quality systems. This individual will collaborate closely with Quality, Regulatory, Clinical, Engineering, and Risk Management teams to drive data-informed decision-making and continuous improvement initiatives.

Key Responsibilities

• Monitor complaints, perform statistical trending, and conduct signal evaluations to identify emerging product quality and patient safety concerns.
• Assess signals and communicate findings, recommendations, and escalations to management review boards and key stakeholders.
• Develop, maintain, and enhance complaint monitoring tools aligned with risk management documentation, product hazards, and surveillance requirements.
• Perform ad hoc data analyses in support of Quality, Regulatory, Clinical, Engineering, and other business partners.
• Design, maintain, and validate Power BI dashboards, reports, visualizations, and analytical tools.
• Apply statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.
• Partner with Risk Management teams to ensure surveillance activities align with product risks and evolving post-market requirements.
• Support process improvement initiatives through automation, data visualization, and workflow optimization.
• Investigate data anomalies and recommend improvements to data quality, monitoring effectiveness, and signal detection capabilities.
• Present analytical findings to technical and non-technical audiences through reports, presentations, and visual dashboards.
• Support audit readiness efforts and maintain compliance with applicable quality system and regulatory requirements.
• Contribute to innovative analytical approaches, including predictive analytics, machine learning applications, and advanced statistical techniques where appropriate.

Quality System Responsibilities

• Incorporate quality principles into all aspects of work.
• Maintain compliance with internal procedures, quality system requirements, applicable regulations, and company standards.
• Support ongoing quality and regulatory compliance initiatives.

Required Qualifications

Education

Bachelor's degree in one of the following disciplines:

• Statistics
• Mathematics
• Computer Science
• Data Science
• Analytics
• Related technical field

Experience

• 0-3 years of experience in data analytics, statistical analysis, quality engineering, post-market surveillance, or a related field.
• Experience working with data analysis and reporting tools preferred.
• Familiarity with Power BI, statistical analysis techniques, and SPC methodologies is highly desirable.

Preferred Skills

• Power BI dashboard development and reporting
• Statistical analysis and trend identification
• Statistical Process Control (SPC)
• Data visualization and reporting
• Complaint monitoring and post-market surveillance
• Risk assessment and signal detection
• Process improvement and automation
• Cross-functional collaboration and communication