Quality Manager (Medical Devices)

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

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

Company

hirify.global is a worldwide organization providing medical products and related healthcare solutions.

What you will do

• Manage quality and regulatory compliance for assigned products, processes, departments, and distribution regions.
• Ensure compliance with QSR, GMP, ISO, 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR requirements.
• Coordinate with divisions, suppliers, manufacturing, operations, and customers to maintain product quality and satisfaction.
• Manage complaints, investigate quality issues, and develop solutions to prevent recurrence.
• Lead continuous improvement initiatives and support product evaluations, design activities, testing, inspections, and process validations.
• Oversee daily operations, staffing, performance management, training, work allocation, and policy implementation for assigned employees or teams.

Requirements

• Bachelor’s degree in engineering, science, or a technical field, or equivalent experience.
• At least 4 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated-industry compliance.
• Broad knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, and related standards and regulations.
• Ability to analyze and report data, identify trends and issues, coordinate concurrent projects, and manage competing deadlines.
• Advanced Microsoft Excel skills, including pivot tables and data analysis functions.
• Ability to work in Northfield, Illinois and travel up to 25% for business purposes.

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.
• Continuing education and training opportunities.
• 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 eligible employees.
• Commitment to diversity, inclusion, belonging, and career growth.