Supplier Quality Engineer

TL;DR

Supplier Quality Engineer: Supporting instrument, cassette, and reagent manufacturing by managing supplier quality improvement programs and ensuring compliance with regulatory standards. Focus on driving continuous improvement, conducting supplier audits, and managing engineering change controls to maintain high-quality diagnostic solutions.

Location: Must be based in Northbrook, Illinois, USA

Salary: $69,000–$117,000 annually

Company

hirify.global is a global leader in immunodiagnostic and molecular diagnostic solutions, dedicated to advancing science to improve patient outcomes worldwide.

What you will do

• Monitor and measure supplier performance through production statistics, field data, and audits.
• Lead supplier selection, qualification, and quality improvement initiatives for new and existing products.
• Act as the technical liaison between suppliers and manufacturing plants to resolve quality issues.
• Participate in Material Review Boards and Supplier Review Boards to drive corrective actions.
• Manage engineering change controls and ensure raw material specifications meet quality standards.
• Conduct supplier audits and report findings to ensure compliance with FDA and cGMP guidelines.

Requirements

• Bachelor's Degree in a technical field or 7+ years of equivalent experience.
• 4+ years of quality, supplier quality, or manufacturing experience in a relevant industry.
• Thorough knowledge of FDA regulations and cGMP guidelines.
• Strong statistical and data analysis skills, including SPC and DOE.
• Ability to travel up to 20% domestically and 5% internationally.
• Must be authorized to work in the United States.

Nice to have

• ASQ Certified Quality Engineer certification.
• Experience with CMM automated inspection methods.

Culture & Benefits

• Comprehensive health benefits, retirement, and financial wellbeing plans.
• Supportive culture focused on accountability, inclusion, and continuous professional development.
• Opportunities to contribute to solutions that directly improve patient care.
• Annual incentive program based on individual and organizational performance.