Quality Engineer - Essential Wound Care (Medical Devices)

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

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

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 apply statistical process control to analyze variation, process performance, and process changes.
• Perform product testing, analyze defects and trends, and lead corrective actions.
• Collaborate with suppliers on quality issues, corrective actions, supplier qualifications, and quality improvement programs.
• Support product development, design control, risk management, CE Technical Files, and regulatory submissions including 510(k) documents.
• Lead investigations of non-conformances and out-of-specification results, and develop preventive and corrective 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 systematic problems, and determine when escalation is needed.
• Ability to travel up to 15% of the time.

Nice to have

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

Culture & Benefits

• Health insurance, life and disability coverage, 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 part-time employees.
• Inclusive workplace focused on belonging, career growth, and providing resources for employees to perform effectively.