Quality Engineer (Medical Devices)

Location: Hybrid in Mundelein, Illinois, United States

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

Company

hirify.global is a growing worldwide medical device organization offering quality, regulatory, and product-focused career opportunities.

What you will do

• Manage post-market surveillance, complaint trending, adverse event monitoring, and product performance analysis.
• Conduct complaint and field issue investigations, determine reportability and root cause, and recommend corrective actions.
• Lead and support nonconformance, complaint, adverse event, and CAPA investigations.
• Support MDR, Vigilance Reports, field actions, recalls, health hazard evaluations, and regulatory inquiries.
• Partner with Regulatory Affairs, Medical Affairs, Operations, and Product Management to assess product safety risks.
• Prepare quality metrics, trend reports, surveillance summaries, and effectiveness monitoring for management reviews and audits.

Requirements

• Bachelor’s degree in engineering, science, mathematics, or another related technical field.
• At least 2 years of experience in quality or engineering.
• Ability to work independently, prioritize multiple projects, solve problems systematically, and determine when escalation is needed.
• Experience with Microsoft Office Suite, including intermediate Microsoft Excel skills such as formulas, tables, conditional formatting, and charting.
• Ability to support compliance with FDA, ISO 13485, MDR, and other applicable quality system requirements.

Nice to have

• Experience with complaint handling, post-market surveillance, MDR or Vigilance reporting, CAPA management, risk management, field actions, or medical device quality systems.
• Knowledge of FDA 21 CFR Part 803, Part 820/QMSR, ISO 13485, and EU MDR post-market requirements.
• Experience performing complaint investigations, trend analysis, and regulatory reporting in the medical device industry.

Culture & Benefits

• Competitive total rewards package with continuing education and training.
• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for employees working fewer than 30 hours per week.
• Focus on inclusion, belonging, diversity, and career growth.