Quality Engineer (Medical Devices)

Location: Northfield, Illinois, United States. Full-time onsite role with up to 15% travel.

Salary: $79,000–$119,000 annually, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare organization offering medical products and related services.

What you will do

• Develop and implement methods for process control, validation, improvement, testing, and inspection of advanced wound care products.
• Design experiments and apply statistical process control to analyze variation, process changes, defects, and failure rates.
• Lead supplier quality activities, including supplier qualification, corrective actions, CAPA, and SCAR implementation.
• Support product development, design control, risk management, regulatory reviews, and CE technical files.
• Build and maintain Device Master Records, product specifications, design control files, and quality documentation.
• Lead investigations of non-conformances and out-of-specification results and develop corrective and preventive actions.

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 standards such as 21 CFR 820 and ISO 13485.
• Intermediate Microsoft Excel skills, including formulas, tables, conditional formatting, and charting.
• Ability to work independently, manage multiple projects, solve problems, and determine when escalation is required.
• Ability to work onsite in Northfield, Illinois, with up to 15% travel.

Nice to have

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

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 applicable employees.
• Inclusive workplace focused on belonging, diversity, and career growth.