Senior Engineer Quality (Medical Devices)

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

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, regulatory, and product development opportunities.

What you will do

• Develop and implement methods for process control, process validation, process improvement, testing, and inspection.
• Design experiments and apply statistical process control to analyze process variation and evaluate process changes.
• Conduct product testing, analyze defects and trends, and lead corrective and preventive actions.
• Lead supplier qualifications and collaborate with suppliers on quality issues, CAPA, SCAR, and improvement programs.
• Provide quality expertise for product development, design control, risk management, CE technical files, and Device Master Records.
• Coordinate laboratory testing, regulatory documentation, compliance reviews, and investigations of non-conformances and out-of-specification results.

Requirements

• Bachelor’s degree in engineering, science, mathematics, or a related technical field.
• At least 4 years of experience in quality or engineering.
• Knowledge of quality standards and regulations including 21 CFR 820, ISO 13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.
• Experience working independently, managing multiple projects, solving complex problems, and leading cross-functional teams.
• Advanced Microsoft Excel skills, including pivot tables, formulas, conditional formatting, tables, reporting, and charting.
• Ability to travel up to 15% and work in Chicago, Illinois.

Nice to have

• At least 5 years of industry experience in medical devices, drugs, or directly related fields.
• Knowledge of advanced Six Sigma and Lean concepts.

Culture & Benefits

• Competitive total rewards package with health insurance, life and disability coverage, 401(k) contributions, and paid time off.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access.
• Inclusive workplace focused on belonging, diversity, and career growth.