Senior Quality Engineer (Medical Devices)

Location: Northfield, Illinois, United States; up to 15% travel

Salary: $101,000–$152,000 annual, plus bonus and/or incentive eligibility

Company

hirify.global is a growing worldwide medical products organization offering total rewards, continuing education, and career development opportunities.

What you will do

• Develop and implement methods for process control, validation, improvement, testing, and inspection.
• Design experiments and apply statistical process control to identify process variation and evaluate changes.
• Lead product testing, quality trend analysis, non-conformance investigations, and corrective and preventive actions.
• Collaborate with suppliers on quality issues, CAPA, SCAR, supplier qualification, and improvement programs.
• Provide quality expertise for product development, design controls, risk management, Device Master Records, and CE technical files.
• Review quality and design documentation for regulatory compliance and coordinate testing with internal and external laboratories.

Requirements

• Bachelor’s degree in engineering, science, mathematics, or a related technical field.
• At least 4 years of experience in quality or engineering; 5 years in medical devices, drugs, or related industries is preferred.
• Experience with quality standards and regulations including 21 CFR 820, ISO 13485, 21 CFR 210/211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.
• Ability to work independently, manage multiple projects, solve systematic problems, and lead cross-functional teams.
• Advanced Microsoft Excel skills, including pivot tables, formulas, conditional formatting, tables, reporting, and charting.
• Up to 15% travel is required.

Nice to have

• Knowledge of advanced Six Sigma and Lean concepts.

Culture & Benefits

• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.
• Inclusive workplace focused on belonging, diversity, and career growth.