Sr Engineer Quality (Medical Devices)

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

Salary: $101,000–$152,000 annually; bonus and/or incentive eligible

Company

hirify.global develops and supplies medical products through a growing worldwide organization.

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 changes, defects, and failure rates.
• Lead supplier qualifications, collaborate on supplier quality issues, and drive corrective actions through CAPA and SCAR processes.
• Provide quality expertise for product development, design controls, risk management, Device Master Records, product specifications, and CE technical files.
• Support regulatory documentation, including 510(k) submissions and letters to file, and coordinate testing with internal and external laboratories.
• Lead investigations of non-conformances and out-of-specification results, while training employees and acting as Quality lead when needed.

Requirements

• Bachelor’s degree in Engineering, Science, Mathematics, or a related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience with quality assurance codes and standards, including 21 CFR 820, ISO 13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.
• Ability to work independently, prioritize multiple projects, solve problems systematically, and lead cross-functional teams.
• Advanced Microsoft Excel skills, including pivot tables, conditional formatting, formulas, tables, and charting.

Nice to have

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

Culture & Benefits

• Competitive total rewards package with continuing education and training.
• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for applicable part-time employees.
• Inclusive workplace focused on belonging, career growth, and providing resources for employees to perform at their best.