Sr. Quality Engineer (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 organization providing medical products and services.

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 product and process variation.
• Perform product testing, analyze defects and trends, and lead corrective actions.
• Lead supplier qualifications and collaborate with suppliers on quality issues, CAPA, and SCAR activities.
• Provide quality expertise for product development, design control, risk management, CE technical files, and regulatory submissions.
• Build and maintain Device Master Records, product specifications, design-control files, and quality documentation.

Requirements

• Bachelor’s degree in Engineering, Science, Math, or a related technical field.
• 4+ years of experience in Quality or Engineering.
• Knowledge of quality regulations and standards 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 problems systematically, and leading cross-functional teams.
• Advanced Microsoft Excel skills, including pivot tables, conditional formatting, formulas, and charting.
• Ability to travel up to 15%.

Nice to have

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

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 part-time employees.
• Commitment to diversity, inclusion, and career development.