Quality Manager (Medical Devices)

Location: Hybrid in Chicago, Illinois, United States; travel up to 25% within the state, out of state, and internationally.

Salary: $116,000–$174,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a healthcare products organization offering medical device and related product solutions.

What you will do

• Manage quality and regulatory compliance across applicable products, processes, product life cycles, and distribution regions.
• Coordinate with divisions, suppliers, manufacturing, and operations to ensure product quality and customer satisfaction.
• Manage customer complaints, investigate quality issues, and develop effective problem-solving approaches.
• Lead continuous improvement projects and support product evaluations from quality assurance and regulatory perspectives.
• Plan and support design, testing, inspection, and process validation activities.
• Manage day-to-day operations, staffing, performance reviews, training, work assignments, and policy implementation for the assigned group.

Requirements

• Bachelor’s degree in engineering, science, or a technical field, or relevant experience.
• At least 4 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated quality systems.
• Knowledge of QSR, GMP, ISO 13485, ISO 14971, MDSAP, MDR, and 21 CFR 820 requirements.
• Ability to analyze and report data, manage concurrent projects, competing priorities, and critical deadlines.
• Advanced Microsoft Excel skills, including pivot tables and data analysis functions.
• Up to 25% business travel is required.

Nice to have

• At least 2 years of supervisory or managerial experience.
• Experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.

Culture & Benefits

• Competitive total rewards package with bonus and/or incentive eligibility.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Inclusive workplace focused on belonging, diversity, and career growth.