Director of Quality Manufacturing (Medical Devices)

Location: Mankato, Minnesota, United States. The role is based at the Mankato manufacturing site and requires up to 30% travel within the state, across the United States, and internationally.

Salary: $154,000–$231,000 annually, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare manufacturing organization producing branded medical products and operating regulated manufacturing and supplier networks.

What you will do

• Lead quality teams and provide strategic, tactical, and operational direction for assigned departments.
• Develop product specifications, testing requirements, inspection procedures, and qualification methods for products and suppliers.
• Build and implement quality strategies based on quarterly management reviews.
• Partner with supplier audit teams, suppliers, manufacturing partners, product managers, and operations to implement quality assurance programs.
• Oversee Quality System Regulation requirements and ensure compliance through FDA, ISO, and internal audits.
• Manage budgets, staffing, performance reviews, training, work assignments, and departmental policies.

Requirements

• Bachelor’s degree in engineering, science, or a technical field.
• At least 7 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated quality systems.
• At least 4 years of management experience; 6 years is preferred.
• Technical knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, GMP, and related standards.
• Experience analyzing and reporting data, coordinating concurrent projects, and managing competing deadlines.
• Advanced Microsoft Excel skills and willingness to travel up to 30%.

Nice to have

• At least 8 years of related experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.

Culture & Benefits

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