Site Quality Assurance Engineer II (Medical Device)

Location: Deerfield, Wisconsin, United States; hybrid or on-site with regular presence at a manufacturing or operational facility. Occasional travel may be required for training, audits, investigations, or multi-site support.

Annual salary: $97,000–$120,000, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

• Lead investigations into manufacturing and process quality issues, including root cause analysis, data review, and corrective action recommendations.
• Support Material Review Board activities and resolve nonconforming materials through documentation, disposition support, and cross-functional coordination.
• Lead manufacturing CAPA and nonconformance investigations, including corrective action follow-up.
• Analyze yield, scrap, rework, and process capability data to identify trends and improvement opportunities.
• Support process validation, equipment qualification, new product introduction readiness, audits, and inspection readiness.
• Maintain quality records and drive continuous improvement in manufacturing quality and quality system effectiveness.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• At least 5 years of experience in quality engineering, manufacturing quality, or a related engineering role.
• Experience leading investigations, root cause analysis, manufacturing quality improvement, nonconformance management, and CAPA processes.
• Knowledge of statistical process control, process capability analysis, data-driven problem solving, and manufacturing quality methodologies.
• Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.
• Advanced English and ability to work in a hybrid or on-site environment in Deerfield, Wisconsin.

Nice to have

• Medical device manufacturing experience.
• Experience with process validation, equipment qualification, new product introduction, MRB activities, and manufacturing CAPA investigations.
• ASQ Certified Quality Engineer or similar certification.

Culture & Benefits

• Work focused on improving patient outcomes and supporting lifesaving medical technologies.
• Collaboration across Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams.
• Hybrid or on-site work arrangement with occasional travel.
• Annual bonus eligibility and comprehensive benefits.