Quality Engineer - Proxima (Medical Devices)

Location: Chicago, Illinois, United States. The role requires up to 15% travel.

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

Company

hirify.global is a growing worldwide medical products organization offering quality engineering opportunities across product development and manufacturing.

What you will do

• Develop and implement methods for process control, validation, improvement, testing, and inspection.
• Design experiments and analyze data using statistical process control to identify process variation and improve product quality.
• Lead product testing, defect analysis, trend evaluation, non-conformance investigations, and corrective and preventive actions.
• Manage supplier quality issues, qualifications, corrective actions, and improvement programs with supplier representatives.
• Support product development, design control, risk management, CE technical files, DMRs, product specifications, and 510(k) submissions.
• Review quality documentation for compliance with domestic and international regulations and coordinate testing 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.
• Ability to work independently, manage multiple projects, solve systematic and mathematical problems, and determine when escalation is required.
• Must be based in Chicago, Illinois, and able to travel up to 15%.

Nice to have

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

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