Post-Market Quality Engineer - Essential Wound Care (Medical Devices)

Location: Chicago, Illinois, United States; up to 15% travel required.

Salary: $79,000–$119,000 annual; bonus and/or incentive eligible.

Company

hirify.global is a growing worldwide medical products organization offering medical device and healthcare solutions.

What you will do

• Lead post-market surveillance and complaint trending by analyzing defective products, field performance metrics, and complaint data.
• Prepare quarterly and annual reports, identify trends, and implement corrective actions using statistical methods.
• Conduct root cause analyses for escalated complaints and develop and execute risk-based test plans.
• Coordinate product testing with internal and external laboratories, including competitor product analysis when needed.
• Maintain compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and other global regulations covering recalls, adverse events, health hazard evaluations, and change controls.
• Lead non-conformance investigations, CAPA, supplier SCARs, QMS activities, audits, management reviews, and post-market KPI reporting.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical field.
• At least 2 years of experience in Quality or Engineering.
• Knowledge of post-market surveillance, complaint handling, risk management, and ISO 14971.
• Working knowledge of FDA 21 CFR 820, ISO 13485, and related quality assurance standards.
• Proficiency with statistical analysis tools, MS Office Suite, QMS software, and complaint handling systems.
• Strong problem-solving, communication, cross-functional collaboration, project management, and deadline management skills.

Nice to have

• Medical device, pharmaceutical, or directly related industry experience.
• Hands-on experience with complaint trending, root cause investigations, and risk-based corrective action decisions.

Culture & Benefits

• Competitive total rewards package with continuing education and training.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for applicable employees.
• Inclusive workplace focused on belonging, career growth, and equitable opportunities.