Site Quality Assurance Engineer II (Medical Devices)

Location: US WI Deerfield, United States of America; 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, recommendations, and corrective-action follow-up.
• Support Material Review Board activities and resolve nonconforming materials through documentation, disposition support, and cross-functional coordination.
• Analyze yield, scrap, rework, and process capability data to identify trends and improve manufacturing quality.
• Support process validation, equipment qualification, and new product introduction readiness through documentation review and quality assessments.
• Partner with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues.
• Participate in internal and external audits, inspection readiness, regulatory compliance activities, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• 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 activities.
• Knowledge of statistical process control, process capability analysis, statistical analysis tools, and data-driven problem solving.
• Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.
• Advanced English proficiency and ability to work in a hybrid or on-site environment in Deerfield, Wisconsin.

Nice to have

• Experience in medical device manufacturing, process validation, equipment qualification, and new product introduction support.
• ASQ Certified Quality Engineer or similar certification.

Culture & Benefits

• Work in a fast-growing medical technology company operating in more than 140 countries.
• Culture focused on innovation, self-motivation, and an entrepreneurial spirit.
• Annual bonus eligibility and comprehensive benefits plans.
• Work supporting technologies intended to improve patient outcomes and save lives.