Principal Product Performance Quality Engineer

Advantage Technical; Arden Hills (MN); Hybrid; USD 83,000 - 106,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Health Savings Account (HSA)

AD&D Insurance

Commuter/Parking Accounts

Job summary

Advantage Technical is seeking a Principal Product Performance Quality Engineer in Arden Hills, MN. The role focuses on data analysis, post-market surveillance, and product performance monitoring to drive quality improvements across the organization.

The position requires 7+ years in medical device quality, strong statistics, and advanced Excel capabilities, with a hybrid work arrangement and pay up to $77/hour.

Qualifications

• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related field.
• 7+ years of experience in medical device quality, post-market surveillance, complaint handling, reliability engineering, or product performance monitoring.
• Experience with complaint trending, signal detection, or quality engineering methodologies.
• Strong statistical analysis and risk assessment skills.
• Advanced Microsoft Excel proficiency.
• Experience in regulated environments and cross-functional teams.
• Knowledge of FDA, EU MDR, or related quality system requirements is preferred.

Responsibilities

• Analyze product performance and complaint data to identify trends, signals, and quality concerns.
• Develop and maintain complaint monitoring and post-market surveillance strategies.
• Perform statistical analyses and evaluate product performance metrics.
• Partner with Quality, Regulatory, Clinical, Manufacturing, and Engineering teams.
• Investigate emerging product issues and support corrective actions.
• Document technical assessments, monitoring criteria, and quality decisions.
• Support audits, inspections, and continuous improvement initiatives.
• Utilize advanced Excel skills to evaluate data and generate reports.

Skills

Statistical analysis

Risk assessment

Quality engineering methodologies

Cross-functional collaboration

Advanced Excel

Regulated environments

Education

Bachelor's degree in Engineering/Quality/Statistics/Life Sciences

Tools

Microsoft Excel

Job description

Principal Product Performance Quality Engineer

Location: Arden Hills, MN (Hybrid)

Pay Rate: Up to $77/hour

Are you an experienced Quality Engineer with a passion for data analysis, post-market surveillance, and product performance monitoring? Join a leading medical device team and play a critical role in improving product quality, complaint monitoring strategies, and risk-based decision making.

Job Duties

• Analyze product performance and complaint data to identify trends, signals, and quality concerns.
• Develop and maintain complaint monitoring and post-market surveillance strategies.
• Perform statistical analyses and evaluate product performance metrics.
• Partner with Quality, Regulatory, Clinical, Manufacturing, and Engineering teams.
• Investigate emerging product issues and support corrective actions.
• Document technical assessments, monitoring criteria, and quality decisions.
• Support audits, inspections, and continuous improvement initiatives.
• Utilize advanced Excel skills to evaluate data and generate reports.

Education Requirements

• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related technical field.

Experience Requirements

• 7+ years of experience in medical device quality, post-market surveillance, complaint handling, reliability engineering, or product performance monitoring.
• Experience with complaint trending, signal detection, or quality engineering methodologies.
• Strong statistical analysis and risk assessment skills.
• Advanced Microsoft Excel proficiency.
• Experience working in regulated environments and cross-functional teams.
• Knowledge of FDA, EU MDR, or related quality system requirements is preferred.

Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD&D Insurance

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

About Us

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.