Sr Engineer Quality - Operating Room Division (Medical Devices)

Location: Chicago, 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 quality, engineering, and regulatory-focused career 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 analyze process variation and product quality.
• Lead product testing, defect analysis, non-conformance investigations, CAPA, and corrective actions.
• Manage supplier quality activities, including supplier qualification, SCARs, and corrective action implementation.
• Support product development, design controls, risk management, Device Master Records, CE technical files, and 510(k) submissions.
• Train and coach employees and act as the quality lead when Quality Management is unavailable.

Requirements

• Bachelor’s degree in engineering, science, mathematics, or a related technical field.
• At least 4 years of experience in quality or engineering.
• Experience applying quality standards such as 21 CFR 820, ISO 13485, 21 CFR 210/211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.
• Experience leading cross-functional teams, solving problems systematically, and managing multiple projects independently.
• Advanced Microsoft Excel skills, including pivot tables, formulas, conditional formatting, tables, and charting.

Nice to have

• At least 5 years of experience in medical devices, drugs, or a directly related industry.
• Advanced Six Sigma and Lean knowledge.

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.