Dir - Quality Manufacturing (Medical Devices)

Location: Glens Falls, New York, United States; travel up to 30% within the state, out of state, and internationally.

Salary: $154,000–$231,000 annual; bonus and/or incentive eligible.

Company

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

What you will do

• Lead Quality teams and develop long-term strategies, functional plans, budgets, and operational priorities.
• Direct product specification development, including testing requirements, inspection methods, qualification, and supplier evaluation.
• Partner with Supplier Audit, manufacturing, operations, suppliers, and product managers to implement quality assurance programs.
• Oversee QSR compliance and readiness for FDA, ISO, and internal audits.
• Present quality information to customers and act as a liaison with senior leadership and business divisions.
• Hire, develop, evaluate, and manage staff across multiple departments and managers.

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 of managerial experience preferred.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, QSR, and GMP requirements.
• Ability to analyze and report data, coordinate concurrent projects, manage competing priorities, and meet critical deadlines.
• Advanced Microsoft Excel skills and willingness to travel up to 30% for business purposes.

Nice to have

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

Culture & Benefits

• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.
• Focus on inclusion, belonging, career growth, and resources that support employee performance.