Quality Engineer

Pro Staff; Arden Hills (MN); On-site; USD 74,000 - 102,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Pet Insurance

401(k) Retirement Savings Plan

Health Savings Account (HSA)

Employee Assistance Program (EAP)

Commuter/Parking Accounts

AD&D Insurance

People Perks Program

Job summary

Pro Staff in Arden Hills, MN is seeking a Quality Engineer with experience in post-market surveillance, data analytics, quality engineering, and statistical analysis to support product quality, patient safety, and regulatory compliance initiatives.

This onsite role offers the opportunity to work with cross-functional teams to monitor product performance and drive continuous improvement in a regulated environment.

Qualifications

• Bachelor's degree in Statistics, Mathematics, Computer Science, Engineering, Data Science, Analytics, or related field.
• 4-7 years of experience in quality engineering, post-market surveillance, statistical analysis, data science, or product performance monitoring.
• Experience with Power BI, data visualization, trend analysis, and SPC methodologies.

Responsibilities

• Perform complaint trending, signal detection, and post-market surveillance activities to identify product quality and performance concerns.
• Analyze large datasets using statistical methods and SPC techniques.
• Develop, maintain, and validate Power BI dashboards, reports, and data visualizations.
• Conduct signal assessments and communicate findings, recommendations, and risks to stakeholders.
• Partner with Quality, Engineering, Regulatory, Clinical, and Risk Management teams to support data-driven decision-making.
• Investigate data anomalies, support root cause analysis, and recommend process improvements.
• Assist with audit readiness, quality system compliance, and continuous improvement initiatives.
• Support the development of automated monitoring tools and advanced analytics solutions.

Skills

Data analytics

Statistical analysis

Power BI

SPC

Trend analysis

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor's degree in Statistics/Mathematics/CS/Engineering

Tools

Power BI

Job description

Quality Engineer

Location: Arden Hills, MN (Onsite)

Pay Rate: $64.00/hour

We are seeking a Quality Engineer with experience in post-market surveillance, data analytics, quality engineering, and statistical analysis to support product quality, patient safety, and regulatory compliance initiatives. This onsite role offers the opportunity to work with cross-functional teams to monitor product performance, identify trends, and drive continuous improvement in a regulated environment.

Key Responsibilities

• Perform complaint trending, signal detection, and post-market surveillance activities to identify product quality and performance concerns.
• Analyze large datasets using statistical methods and Statistical Process Control (SPC) techniques.
• Develop, maintain, and validate Power BI dashboards, reports, and data visualizations.
• Conduct signal assessments and communicate findings, recommendations, and risks to stakeholders.
• Partner with Quality, Engineering, Regulatory, Clinical, and Risk Management teams to support data-driven decision-making.
• Investigate data anomalies, support root cause analysis, and recommend process improvements.
• Assist with audit readiness, quality system compliance, and continuous improvement initiatives.
• Support the development of automated monitoring tools and advanced analytics solutions.

Qualifications

• Bachelor's degree in Statistics, Mathematics, Computer Science, Engineering, Data Science, Analytics, or a related technical field.
• 4-7 years of experience in quality engineering, post-market surveillance, statistical analysis, data science, or product performance monitoring.
• Experience with Power BI, data visualization, trend analysis, and SPC methodologies.
• Strong analytical, communication, problem-solving, and cross-functional collaboration skills.
• Must be authorized to work in the U.S. without current or future visa sponsorship.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Pet Insurance
• 401(k) Retirement Savings Plan
• Health Savings Account (HSA)
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• AD&D Insurance
• People Perks Program