Quality Engineer - Remedy & Readycare (Medical Devices)

Location: Chicago, Illinois, United States; onsite role with up to 15% travel

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

Company

hirify.global is a growing worldwide healthcare organization providing medical products and related solutions.

What you will do

• Develop and implement methods for process control, validation, improvement, testing, and inspection.
• Design experiments and analyze process data using statistical process control, probability, and statistical quality methods.
• Perform product testing and investigate defects, failures, non-conformances, and out-of-specification results.
• Lead supplier qualifications and collaborate with suppliers on corrective actions, CAPA, and SCAR activities.
• Support product development, design control, risk management, CE technical files, Device Master Records, and product specifications.
• Coordinate regulatory documentation and product testing, including 510(k) submissions and work with internal and external laboratories.

Requirements

• Bachelor’s degree in Engineering, Science, Math, or a related technical field.
• At least 2 years of experience in Quality or Engineering.
• Working knowledge of quality assurance codes and standards, including 21 CFR 820 and ISO 13485.
• Intermediate Microsoft Excel skills, including conditional formatting, tables, formulas, and charting, plus experience with Microsoft Office.
• Ability to work independently, manage multiple projects, solve problems systematically, and determine when escalation is necessary.
• Ability to work in Chicago, Illinois, and travel up to 15%.

Nice to have

• At least 2 years of industry experience in medical devices, drugs, or a directly related field.

Culture & Benefits

• Competitive total rewards package.
• Continuing education and training opportunities.
• 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 eligible employees.
• Focus on diversity, inclusion, belonging, and career development.